Dongguan Dongyangguang Pharmaceutical R&D Co. Ltd.

Novartis has officially petitioned the Supreme Court in an ongoing effort to protect Gilenya from generic rivals for at least another several years. The Swiss pharma giant filed the 55-page document Wednesday, after announcing its intent to petition the court in September. The case dates back to 2016, when HEC Pharm filed for generic approval of its own version of Gilenya, Novartis’s blockbuster multiple sclerosis drug. The generic won approval in 2019, but Novartis fought back with lawsuits asserting that various patents don’t expire until 2027. A federal court in Delaware previously granted a permanent injunction against HEC’s generic until a patent covering a 0.5 mg dosing regimen of Gilenya expires in 2027, and a three-judge appeals panel upheld the decision last January. However, a new judge — who joined the panel after a prior member retired — agreed to grant a rehearing and the panel reversed the ruling in June, invalidating Novartis’s ‘405 patent. Novartis argued in its Supreme Court petition last week that the high court should “bring the Federal and Ninth Circuits in line with the law and sound judicial practice.” “Allowing panel changes to overturn already-entered decisions undermines confidence in the judiciary. It creates an impression that circuit courts administer judge-specific justice, with outcomes depending not on the merits but on which judges are assigned to the panel,” the petition reads. Novartis had requested a stay on the lower court’s mandate while it prepared its petition, which the Supreme Court denied in October. HEC’s version launched in October, according to court documents. Last year, Novartis said it expected to lose about a quarter billion dollars in 2022 sales if generics were to hit the market. On Jan. 11, Novartis filed yet another complaint against HEC in Delaware federal court, alleging that the generic drug’s labeling — including instructions to first test patients for the virus that causes chickenpox — infringes on its patent ‘179, which also expires in 2027. “If Defendants’ infringement of the ’179 patent is not permanently enjoined, Novartis will suffer substantial and irreparable harm for which there is no remedy at law,” the company said. Gilenya earned nearly $2.8 billion in 2021, making it Novartis’ third-highest seller in its Innovative Medicines segment. HEC has previously accused Novartis of making $3.8 million per day on Gilenya in the US, “charging at least 10 to 20 times what its generic competitors would.” “Novartis continues to vigorously defend the validity of US Patent No. 9,187,405, covering a dosing regimen for 0.5mg,” Novartis said in an email to Endpoints News on Tuesday. “The process may take several months to determine if the petition will be granted.” HEC Pharm was not immediately available for comment.

WASHINGTON, Oct 13 (Reuters) - The U.S. Supreme Court on Thursday turned down Novartis' (NOVN.S) bid to block the launch of generic versions of the company's blockbuster multiple sclerosis drug Gilenya in a dispute with China's HEC Pharm Co Ltd (1558.HK) and other generic drugmakers. Novartis had asked the justices to suspend a lower court's ruling that lifted a ban on generic versions of Gilenya, the Switzerland-based company's third highest-selling drug last year with $2.8 billion in sales. Novartis sued HEC and more than a dozen other generic drugmakers, accusing them of patent infringement, in Delaware federal court after they applied for U.S. Food and Drug Administration (FDA) approval of Gilenya generics. Novartis settled with some of the drugmakers it had sued, allowing for some Gilenya generics before a key patent's 2027 expiration. Companies that settled with Novartis included India-based Aurobindo Pharma Ltd (ARBN.NS) , Dr. Reddy's Laboratories (REDY.NS) and Sun Pharmaceutical Industries Ltd (SUN.NS) , Pennsylvania-based Viatris Inc's (VTRS.O) Mylan Pharmaceuticals and privately held Canada-based Apotex Inc. The FDA in 2010 approved Gilenya, a once-daily pill used to treat relapsing forms of multiple sclerosis, a chronic disease that affects the central nervous system. Novartis said in September that it expects to lose $300 million in sales for the rest of 2022 if the Gilenya generics are launched. The patent-focused U.S. Court of Appeals for the Federal Circuit ruled in June that a key Novartis patent for Gilenya was invalid. U.S. Chief Justice John Roberts, granting a request by Novartis on Sept. 29, temporarily prevented the Federal Circuit from issuing a mandate as planned on Oct. 4 to lift a federal judge's injunction that blocked generic versions of Gilenya based on the Novartis patent claims. Roberts acted after Novartis said that green-lighting the generics would hurt the company in "ways that could be impossible to calculate at an after-the-fact damages trial" and that it was likely to win a Supreme Court appeal of the underlying case. HEC told the Supreme Court that Novartis makes $3.8 million per day from Gilenya sales in the United States alone. "If Novartis does not prevail in this Court, it will improperly extract $3.8 million from payors and patients every day its requested stay remains in effect," HEC said. "And not one penny of those improper monopoly revenues will be recoverable from Novartis by anyone." A spokesperson for Novartis said the company will "continue to vigorously defend the validity of the Gilenya patent" and plans to petition the high court to review the Federal Circuit's decision. Representatives for HEC did not immediately respond to requests for comment. Our Standards: The Thomson Reuters Trust Principles. Thomson Reuters Blake Brittain reports on intellectual property law, including patents, trademarks, copyrights and trade secrets. Reach him at blake.brittain@thomsonreuters.com

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here . Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here . The Endpoints 11 Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. In the months since, we’ve seen the natural Darwinian down cycle take effect. The best of the private startups, though, have continued to thrive in a more difficult fundraising environment. This year’s group of the Endpoints 11 has a wide mix of players. Altogether they represent the best of biotech — and a good example of why biotech’s current disfavor on Wall Street is just another temporary trend, John Carroll writes. bluebird’s $3M gene therapy Things are finally falling into place at bluebird . Just a month after scoring a green light for Zynteglo — to treat beta thalassemia — the FDA came through with an approval for its gene therapy for early, active cerebral adrenoleukodystrophy. But Skysona’s label comes with its own caveats, including a black box warning. And with its $3 million price tag, drug pricing experts say it will serve as a test case for a market that’s approaching prime time, with concessions and risk-sharing agreements baked in. Biogen tout ALS, depression data Biogen and Ionis dropped the full data on the Phase III study of their ALS drug tofersen as the FDA is reviewing the use of the drug in a very small subset of ALS patients. Despite failing the primary endpoint, the companies doubled down on the observation that the antisense therapy reduced levels of neurofilament. Now the decision rests on the FDA to decide whether or not a decrease in neurofilament levels is enough to warrant approval. Meanwhile, with an FDA filing rolling for their big depression drug zuranolone , Biogen and partners at Sage are bringing more data on the drug’s durability in an open-label study. Knives out at ODAC The FDA’s internal review ahead of the Oncologic Drugs Advisory Committee meeting set the tone for Spectrum Pharmaceuticals’ poziotinib and Oncopeptides’ “dangling” accelerated approval for the multiple myeloma drug Pepaxto , as regulators raised significant concerns about their efficacy. And the experts on the panel followed up by voting against granting poziotinib an OK and keeping the accelerated approval for Pepaxto. A day later, the adcomm also gave a thumbs down on Secura Bio’s PI3K inhibitor Copiktra ( duvelisib ), which won an accelerated approval but was tied to a higher number of deaths. PREMIUM PROTABs with a B You’ve heard of PROTACs, the small molecule protein degraders that have taken biopharma by storm. You may have heard of LYTACs. But what about AbTACs, PROTABs or KineTACs? Genentech scientists and researchers at UCSF are out with new papers describing protein-degrading antibodies — technologies using bispecific antibodies to clear target proteins on cancer cells. Lei Lei Wu dives into the science and nuances . #ESMO22 roundtable Still thinking about #ESMO22? You can now rewatch the video or read the transcript of John Carroll’s roundtable discussion with Jean-Charles Soria , the senior vice president oncology therapeutic area head for Amgen ; Priti Hegde , the chief scientific officer for Foundation Medicine ; Antoine Yver , the chairman of development for Centessa; Jeff Legos, executive vice president, global head of oncology for Novartis ; and Jack West , associate professor, vice president of Network Strategy for City of Hope Comprehensive Cancer Center. They cover everything spanning cancer testing, KRAS, combination ideas and the best talk of the meeting. Does science still sell? After a global pandemic that featured endless images of scientists in lab coats, glass vials rolling off assembly lines and serious people peering through microscopes, is it time to take off the lab coats and tone down the overused science imagery? Marketing experts and healthcare agency professionals agree that there likely have been too many scientists in white coats. The real problem, though, isn’t just that science imagery is clichéd or overused, but that it potentially creates a negative boomerang effect amid a general dip in science trustworthiness. DEALS Now that Genfit has shipped off its failed NASH drug to Ipsen , the French biotech’s new vision appears to be coming into sharper focus. It acquired the Swiss startup Versantis for CHF40 million upfront, or roughly $41.4 million, a deal that positions the company in a separate but related rare liver disease: acute-on-chronic liver failure. Takeda managed to offload an experimental cancer drug that’s been sitting on the shelf in exchange for $7 million in cash plus milestones. Puma Biotechnology is the buyer for alisertib , an aurora kinase A inhibitor originally developed at Millennium , which it now plans to develop as a treatment of certain breast cancers as well as small cell lung cancer. GSK likes to take pride in being one of the few Big Pharma players still active in antibiotics R&D. In a move to beef up the pipeline, it is licensing a late-stage antibiotic candidate from Spero Therapeutics — injecting $75 million cash into a struggling biotech that’s crumbled in the wake of an FDA rejection and lending it a hand in completing a new Phase III trial. Rocket Pharma is snapping up Renovacor , a preclinical-stage biotech developing a cardiac gene therapy, in an all-stock deal. The acquisition holds an equity deal value of about $53 million and will add $38 million to Rocket’s cash heap in addition to a pipeline of AAV gene therapies. Renovacor jumped on Nasdaq through a SPAC merger just a year ago. Sesen Bio’s decade-plus journey is over after failing to secure a bladder cancer drug approval and carve its own path for IL-6 antibodies. In its final act, it’s reverse merging with Carisma Therapeutics , whose CAR-M therapies put it above 41 other bidders, according to Sesen. In all, the new Carisma will have $180 million to bring multiple therapies to clinical readouts and keep the lights on through 2024, For $65 million in upfront and option fees, Merck KGaA is allying itself with Italy’s Nerviano Medical Sciences to develop a PARP1 inhibitor for the treatment of BRCA-mutated tumors. While acknowledging they’re going after some blockbuster rivals, the companies say NMS-293 stands out because it’s more selective against PARP1 versus PARP2 — which could make it more tolerable in patients. Allogene Therapeutics , one of the leading players in the race for off-the-shelf CAR-Ts, disclosed that French partner Servier cut off its involvement in a partnership developing therapies directed against CD19, including the most advanced candidates in Allogene’s pipeline. The biotech may now find another company to license ex-US rights to these products. More than two years after claiming a Phase II win in one of the most challenging diseases faced in biotech, Inventiva is handing over rights to its NASH drug in several Asian markets to China’s Sino Biopharm . In exchange for the license to lanifibranor , Sino Biopharm will pay $12 million upfront plus more in biobucks. As Theravance Biopharma tries to plot its comeback, it hashed out a $250 million plan to buy its own shares back from investors. First, it will reclaim all the shares from GSK — one of its major shareholders and a partner since 2002 — for roughly $94 million. The rest will go toward purchasing shares from other stockholders and the open market, ideally by the end of 2023. Swiss pharma Basilea took another step in pivoting to anti-infectives, shedding yet another oncology program by selling the cancer drug BAL0891 to Korean biotech SillaJen for $14 million upfront. Since licensing the mitotic checkpoint inhibitor in 2018, Basilea has landed an IND for the drug, but never started the Phase I trial. CELL & GENE TX Four years after AbbVie signed on to a pact with Calibr — a branch of Scripps Research Institute —around a then-preclinical next-gen CAR-T program, the partners have generated their first-in-human data . The data, they say, support the idea that a switchable CAR-T can be just as effective as traditional ones but be safer for patients. David Liu and his team at the Broad Institute have been awarded a patent for the compositions and methods behind the prime editing of a target DNA molecule — or a gene — that enables a nucleotide change and/or targeted gene mutation. The idea behind prime editing — sometimes dubbed CRISPR 3.0 — was first published in Nature in December 2019. CAR-T player Celyad Oncology sold its manufacturing site to fellow Belgian cell therapy player Cellistic , which was recently spun out from the CRO Ncardia . Sold for €6 million ($5.9 million), the 11,000-square-foot facility is located in the town of Mont-Saint-Guibert. The acquisition will also bring Celyad’s 35 workers under Cellistic’s wing, with plans to make iPSC cell therapies. R&D When Ionis and AstraZeneca unveiled the first round of mid-stage data for their antisense PCSK9 drug, execs underscored the drug’s “potential best-in-class efficacy profile.” But after looking at data from a second Phase IIb trial — which met its primary endpoint — AstraZeneca decided not to pursue a Phase III after all . Merck is scrapping clinical plans for its lead long-acting PrEP candidate for HIV after months of grappling with safety concerns. But it’s marching ahead with trials to test once-daily as well as once-weekly regimens involving the drug, islatravir, as a treatment — albeit at a lower dose than what appeared to have triggered a drop in immune cell counts. Just weeks after it announced a Phase III win for its pain drug after knee replacement, Pacira BioSciences posted another Phase III success in post-bunion surgery pain, reducing both pain and opioid use. The biotech plans to file for label expansion early next year to incorporate the two new indications. As the controversy around Biogen’s Aduhelm reverberates across Alzheimer’s research, Alzheon — a much smaller Massachusetts-based biotech — is claiming (again) it has “industry-leading” data on its own drug. But the one-year update is still lacking in clinical data, with numbers on only biomarkers but not memory test scores. Virios Therapeutics’ experimental treatment for fibromyalgia failed in a mid-stage study , missing the statistical significance on the improvement of pain. But execs blamed the flop on Covid-19, saying they saw a “bifurcation of results” from an initial review — namely that the drug worked differently for patients who were enrolled at different stages of the pandemic. After a recent court win for its inhaled pulmonary arterial hypertension drug, pushing off competition for a few more years, United Therapeutics quietly scrapped a late-stage study of Tyvaso that would’ve expanded the label. The Phase III termination occurred because of a recommendation from the data safety monitoring committee following a routine analysis. PEOPLE Even by Flagship Pioneering standards, the stated goal at Vesalius Therapeutics — unveiled at its $75 million launch this March — was exceedingly ambitious. Six months later, though, the biotech says it needs to focus and scale down a bit, laying off 29 of its 67 employees in order to “refine its strategy” even as it continues to have its eye on a wide range of common diseases. Julian Adams didn’t exactly finish what he set out to do at Gamida Cell , but as he finally steered the company toward its first BLA filing for a cell therapy, he’s passing on the baton . The seasoned biotech exec — who cemented his reputation at Millennium and then Infinity — is stepping down. Abigail Jenkins , an experienced commercial exec, will succeed him as CEO. Creative conglomerate WPP wooed Organon’s chief communications officer Wendy Lund to take up a newly created role as WPP chief client officer for health and wellness. For Lund, it’s a homecoming of sorts as she previously led GCI Group , a WPP healthcare communications agency, as CEO for 11 years. AI The Novo Nordisk Foundation is making a quantum leap. Betting big on what it believes is the future of life sciences, the large Danish charity behind the pharmaceutical company of the same name is ponying up $200 million to try to develop the world’s first quantum computer designed to develop new drugs. More than two years after Pfizer first tied the knot with machine learning company CytoReason , the partners decided to go deeper. In a $110 million deal that includes a $20 million equity investment, Pfizer will tap into CytoReason’s disease models beyond oncology and immunology, as well as new analytical tools. FINANCING Charlottesville, VA-based Rivus Pharmaceuticals is out to corner a new market in the diabetes and weight loss space. And RA Capital is leading a $132 million round that will push its lead candidate, a small molecule “controlled metabolic accelerator,” further along. Having reported positive Phase IIa results, Rivus will spend the cash on a second mid-stage study. With the heat building in the TCR-T cell therapy space, a biotech based in Singapore and California is using machine learning to get in on the action. ImmunoScape bagged $14 million to fuel its tech , which it says can discover targets at scale and screen hundreds of epitopes. The eventual pipeline of new candidates will be designed to hit solid tumors. Bristol Myers Squibb’s landmark TYK2 approval is floating Ventyx’s boat, and the biotech is taking advantage of it. Ventyx, which is developing its own TYK2 inhibitor, put together a private placement to bring in $176.6 million to fuel that and three other programs. Roivant Sciences had about $2 billion at the end of June. But the repeat vant-maker wants the option to secure more money for its apparatus, filing a shelf registration statement to raise up to $1 billion more . But since it’s just a technical filing, the biotech operator doesn’t yet have specific plans for what potential proceeds would go toward. Mixed results are stopping Virios from trying to raise some more cash on Nasdaq. Facing investor backlash for its Phase IIb study in fibromyalgia — which it blamed on Covid-19 — the biotech opted for a public offering while its shares are at an all-time low, an unusual move. It hopes to use the money raised to further advance the candidate that failed. California-based Allakos , which works on allergies and inflammation-related diseases, is making hay while the sun shines. On the back of mixed Phase III results on its lead drug candidate, it sought $150 million via a public offering . It has said it won’t develop the drug further in eosinophilic duodenitis — which produced hit and miss data — but rather focus on atopic dermatitis and chronic spontaneous urticaria. Almost a year after the FDA gave the green light to LA-based Aadi Bioscience’s first drug, the biotech is looking to private investors to keep itself going. The oncology player said it engaged with both new and existing investors in a PIPE financing — selling 3.3 million shares at $12.50 a share. The company is also selling off pre-funded warrants, bringing the total expected raise to $72.5 million . LAW Novartis , which stands to lose more than a quarter billion dollars in sales this year if Gilenya generics are allowed to market, is taking the fight all the way to the Supreme Court . There’s a long back story here with its patent case against private Chinese biotech HEC Pharm , but most recently, a federal appeals court refused to rehear the case. Sandoz is hoping to celebrate its recently announced spinoff from Novartis with swift approvals for its Tysabri biosimilar in both the US and Europe — but not if Biogen can help it. Biogen filed suit against Sandoz earlier this month, according to newly unsealed documents, accusing the company of infringing on multiple Tysabri patents. The drug is used for both multiple sclerosis and Crohn’s disease. Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case against Sanofi and Regeneron . The recommendation is now in and it’s a no . Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.” Merck picked up a win in its patent battle against Viatris regarding sitagliptin, the active ingredient in blockbuster diabetes drugs Januvia and Janumet . The federal ruling put a freeze on a potential Viatris generic until at least 2026, the year several other rivals are also poised to release their generics, pending an appeal. At the request of plaintiffs from a class action lawsuit, a federal court agreed to review J&J’s massive win in bankruptcy court earlier this year. Hoping to revive their claims that the company’s talc products cause cancer, the plaintiffs argued that the “Texas two-step” maneuver meant J&J now has no incentive to handle the lawsuits quickly . Vanda Pharmaceuticals took the FDA to court three separate times this year as it struggles to win over regulators with its sleep and chronic digestive disorder drugs. Dealing from the other side of the table, the company agreed to drop $11.5 million to settle claims — filed by investors — that it illegally promoted the sleep drug and one other off-label. PHARMA As more of its employees start to work remotely, Biogen sold a building in Cambridge, MA, to real estate developer BXP for $592 million. The building, located in Kendall Square, is home to other companies such as Thermo Fisher Scientific and Moderna . Biogen also terminated a lease agreement with BXP for a separate site that will make room for a Broad Institute expansion. With Sandoz soon to be out of the picture, Vas Narasimhan laid out his vision for the new, slimmer Novartis — and it will sport a “US-first mindset.” Ambitions to become a top-five player in the US by 2027 mean ramping up clinical trials in the states and “building capability and talent, among other things.” The company’s also shooting for a top-three ranking in China. Almost exactly five years ago, Teva captured the industry’s attention with its high-profile recruitment of Kåre Schultz at Lundbeck for the top job at the troubled generics giant. And now the CEO has his last year in view as he promises to finish the turnaround he had promised, laying out his next round of cuts, touting some free cash flow and projecting that Teva would start paying out a $4.3 billion settlement over more than a decade, starting next year. Following up on previous pledges to aggressively scrutinize pharma M&A, FTC chair Lina Khan reiterated to a Senate subcommittee that reviewing Big Pharma mergers is a priority . While comparing this merger analysis in the pharma space to the study of public utilities in the 1930s “that exposed rampant financial fraud,” Khan said in prepared testimony that the commission is going to target unlawful conduct. About five weeks after Pfizer said its 20-valent vaccine follow-up to Prevnar 13 was effective in infants in a US study , the Big Pharma now has the data from an EU late-stage trial that will send the jab to the continent’s regulators by year’s end. Not only did the vaccine lead to “long-term protection,” but researchers also reported that it was largely non-inferior to Prevnar 13. The global fund that was established to fight some of the world’s deadliest diseases — HIV, TB, and malaria — raised a record $14.25 billion from donor countries, NGOs and private companies, with a $6 billion pledge from the US. While the total still fell short of its target of raising $18 billion, it’s the largest amount raised since the organization was set up in 2002. MARKETINGRX Eczema, or atopic dermatitis, has kept a fairly low profile among social media influencers, according to a review by the Harris Poll’s expert network for Endpoints News. However, with a handful of newly approved treatment options over the past year and new advertising and marketing campaign launches, that relative quiet may be about to change For the past five years, former New York Yankees slugger Bernie Williams has been the face of Boehringer Ingelheim’s “Breathless” campaign aimed at raising awareness about idiopathic lung disease. Now Boehringer is taking the campaign in a different direction with a focus on music , and Williams, who’s also a Grammy-nominated musician, is coming along. Astellas is breaking new ground with TikTok as the first pharma company involved in the social media channel’s TikTok Pulse program, which places ads next to the most popular content instead of the typical contextual placements in viewers’ personal feeds. In Astellas’ case, the ads are menopause symptom awareness videos created by two women influencers. A dive into the National Football League’s TV commercial buys across early season games by iSpot shows a hefty lead for Pfizer with its Covid-19 Comirnaty vaccine ads. More than 175 million impressions with $9.5 million in media spending put it in the top spot with a 65% share of voice across NFL pharma spending. In a distant second place is Bristol Myers Squibb’s Opdivo . At Klick Health’s first Ideas Exchange conference with biotech and pharma industry insiders since before the pandemic began, it was no surprise many conversations included Covid topics. Yet while vaccines and treatments were discussed, so too were the effects on drug development, federal responses, health inequities — and what to do now and next. Featured speakers included Regeneron’s George Yancopoulos , former BARDA chief Rick Bright and Tal Zaks , previously of Moderna . Klick Health co-founder and CEO Leerom Segal sat down for a one-on-one with former President Barack Obama in New York, a wide-ranging discussion about his time in office and current political divisiveness in the US, but also on some health and science topics. And he has some ideas about how pharma can rebuild trust in science. Continuing to raise awareness, Sanofi debuted its “Just the Flu” ad featuring a wolf and its flu shots; Pfizer and BioNTech are teaming up with the southern college football league to encourage Covid-19 booster shots; AstraZeneca rolled out antibody TV commercial with cancer survivor and actor Jeff Bridges ; catch all these and more in the MarketingRx roundup . FDA+ Four experts from the FDA’s Oncology Center of Excellence took to the New England Journal of Medicine to make the case for not only improving the agency’s ability to expeditiously pull dangling accelerated approvals when, on the rare occasion, confirmatory trials fail, but also better building “quality and efficiency into the AA on-ramp.” It’s unclear whether those policy riders will make it to the bill, but the long and winding road to reauthorizing FDA’s quinquennial user fees for prescription drugs, generics, biosimilars and medical devices finally has a light at the end of it. A senior GOP committee aide confirmed to Endpoints News that at the very least, an agreement has been reached for the FDA user fee deals, which are good through 2027, to be included in the continuing resolution. In the US, the difference between biosimilars and interchangeable biosimilars is stark and carries pragmatic consequences. But the EMA is taking a different stance, making clear in a statement that all biosimilars approved in the EU are interchangeable with their reference product or with an equivalent biosimilar. The ODAC wasn’t the FDA’s only adcomm meeting this week. The Vaccines and Related Biological Products Advisory Committee voted in favor of Ferring Pharmaceuticals’ RBX2660 , an experimental fecal microbiota transplant that the company says would be the first microbiota-based live biotherapeutic to receive an FDA green light. Multiple adcomm members brought up the need for a regulated product amid a largely unregulated landscape. Two rejections later, the FDA was finally ready to approve Fennec Pharma’s drug for lowering the risk of hearing loss among children being treated for cancer with chemotherapy. Pedmark , as it’s called, was granted breakthrough therapy designation and priority review given the severity of the indication, but manufacturing issues held it back for almost two years. Eli Lilly managed to convert the accelerated approval on its RET drug to a full approval after racking up data from more patients and accumulating 18 months of follow-up. First developed at Loxo Oncology , Retevmo (or selpercatinib ) is targeted at locally advanced or metastatic non-small cell lung cancer with a RET, or rearranged during transfection, gene fusion. After massive layoffs in the R&D unit earlier this year in a pivot to commercialization, Heron secured an FDA approval for its post-surgery nausea and vomiting drug. Aponvi is an IV infusion of the NK1 inhibitor aprepitant, which is the same molecule as another approved Heron drug and a bioequivalent of a Merck molecule that’s gone generic. The FDA’s Oncologic Drugs Advisory Committee will meet in November to discuss whether to pull an indication for GSK’s PARP drug Zejula , considering issues with the final overall survival data from the pivotal trial on which the approval was based. The announcement came a week after GSK voluntarily pulled the same indication of Zejula that will be reviewed. Cidara Therapeutics got a boost on its quest to make a mark in the world of antifungals, as the FDA handed priority review to its antifungal rezafungin for the treatment of candidemia and invasive candidiasis — common causes of serious bloodstream infections in hospitalized patients. The drug proved non-inferior to the current standard of care in trials. In another step for Seagen’s portfolio expansion, the FDA granted Tukysa a priority review in combination with Genentech’s Herceptin for second-line HER2-positive metastatic colorectal cancer. The decision comes just a couple of months after Seagen uncorked the full Phase II results at ESMO, boasting a notable improvement in overall survival from the last readout. One of the features Medtronic touts in its MiniMed 600 series insulin pumps is a series of components that connect wirelessly to allow the remote delivery of insulin. But the FDA issued an alert warning that the technology also leaves the door open to potential hackers, when unauthorized users gain control of the pumps in certain circumstances. MANUFACTURING When the Biden administration announced last week, through an executive order, that it is investing $2 billion into domestic efforts to increase biotechnology and biomanufacturing efforts, a lot of ears perked up in the wider manufacturing world. Rahul Singhvi , the CEO of manufacturing company Resilience , was in the West Wing for a summit on biotech and biomanufacturing. Endpoints News’ Tyler Patchen caught up with Singhvi about the impact of the funding on manufacturers and the wider industry, as well as the developments at the company. A Catalent facility in Indiana that produces Covid-19 vaccines is facing scrutiny from the FDA over an inspection last month. The Bloomington plant, which handles fill and finish operations as well as commercial scale biomanufacturing, was hit with a 19-page Form 483 detailing 12 major observations, notably the presence of foreign particles in vials and other quality control issues. AbbVie is injecting €60 million ($58.9 million) into its manufacturing site in the town of Carrigtwohill, Ireland, a suburb of Cork City. According to AbbVie, the 14,000-square-foot facility has been operating since 2001 as a tablet and capsule production site for oncology and virology products. This latest expansion will have the site also support its aesthetics business. The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand. Both drugs, Actilyse and Metalyse , are from Boehringer Ingelheim and are used as emergency treatments for adults experiencing acute myocardial infarction by dissolving blood clots. On a roll, Fujifilm Diosynth , kicked off an expansion project for its microbial manufacturing facility at its campus in the town of Billingham, UK. The 20,000 square-foot, £400 million ($435 million) expansion will add clean rooms, purification suites and a packing area along with more space for the manufacturing itself — boosting capacity by 70%. Phlow , the drug manufacturer that prides itself on making materials in the US instead of relying on sources overseas, is looking to raise $50 million in a funding round. According to a Form D, it has raised $24.2 million from 11 investors since the round kicked off in August. The CDMO outfit iBio is dishing out $1 million upfront to buy several oncology programs from San Diego-based RubrYc Therapeutics . According to iBio, it’s moving more into the drug discovery game and found RubrYc’s AI platform appealing. The deal will also see RubrYc’s computational biologists coming under iBio’s umbrella to work on the AI platform while the wet lab workers for RubrYc will remain in place. As monkeypox cases continue to affect nations in North America and across the globe, Canada is looking to step up its prevention efforts via a boosted contract with Bavarian Nordic . The Canadian public health agency upped its Jynneos contract to $234 million , plus options to buy more of the vaccine spanning the next decade. A Cipla drug manufacturing site in India once again landed in the crosshairs of FDA inspectors . The FDA’s recent visit to its facility in the village of Verna uncovered six observations, as the agency took issue with environmental monitoring and procedures relating to preventing microbial contamination, in addition to cleaning. Two years after breaking ground, Thermo Fisher opened a new $160 million , 85,000 square-foot facility in Chelmsford, MA, 30 miles north of its headquarters in Waltham. The site is part of a wider $650 million investment, and it will produce resins that are used in medicines and biologics as well as cell and gene therapies, A year ago, Canadian antibody shop AbCellera broke ground on the first phase of its headquarters expansion in Vancouver, along with a new manufacturing site in the city. The second part of the project is now underway as it starts building out a campus that will include lab and office space to support wider antibody discovery and development. Lonza is beefing up ADC development and manufacturing capacity at its highly potent API (HPAPIs) suite in Visp, Switzerland; The Center for Breakthrough Medicine earned a multi-year contract to produce jCyte’s cell therapy for the eye; An initiative in Canada will develop new technologies for the manufacturing of cell and gene therapies; You can read all about the snippets in the Manufacturing roundup . DON’T MISS The once-booming SPAC market has been a slog this year, with mergers seemingly falling apart left and right. Aesther Healthcare Acquisition Corp’s new proxy statement details just how choppy the waters have become following the smooth sailing seen in peak pandemic months, as the blank check company recounts how talks fell apart with at least three potential partners before it finally landed a deal with Ocean Biomedical — just before the deadline. Despite some progress, women are still severely underrepresented in the top ranks of biotech, according to a new survey. Of the 200 micro- and small-cap biotech CEOs included in the Bedford Group and Transearch’s latest study, only 17, or 8.5%, self-identified as women . While that could be cause for cautious optimism, it can also be a call to action, the author noted. As part of efforts to slow rising numbers of opioid overdose deaths, FDA commissioner Rob Califf previously committed to a major review of the agency’s opioid decision-making process, including labeling. He revealed that the review will be conducted by experts at The Ohio State University , who will provide “actionable recommendations.”