CMO Moves: Regulatory catalysts for drug manufacturing – March 2023
21 Mar 2023
Drug ApprovalClinical ResultImmunotherapyVaccine
Preview
Source: Pharmaceutical Technology
Image Credit: Shutterstock/Cergios
The biotech industry is currently undergoing a wider financial upheaval after the collapse of Silicon Valley Bank (SVB), which was favoured by many biotech companies. In such turbulent times, ensuring the most efficient and cost-effective manufacturing frameworks becomes even more important. Most pharmaceutical and biotech companies outsource certain production tasks to contract manufacturing organizations (CMOs). Based on the individual contract, these CMOs manufacture small molecules or biological active pharmaceutical ingredients (APIs), as well as packaging material, and are charged with other related functions.
Free Report
How is the Biopharmaceutical industry evolving?
2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape.
GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects.
Access the report to:
Benchmark the impact of major themes on the Biopharmaceutical industry.
Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents.
Evaluate the effects of COVID-19 on the sector.
Download the full report to understand what to expect and how to align your strategies for success.
By GlobalData
Preview
Source: Pharmaceutical Technology
Submit
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Thailand (+66)
Togo (+228)
Tonga (+676)
Trinidad & Tobago (+1868)
Tunisia (+216)
Turkey (+90)
Turkmenistan (+7)
Turkmenistan (+993)
Turks & Caicos Islands (+1649)
Tuvalu (+688)
Uganda (+256)
UK (+44) -->
Ukraine (+380)
United Arab Emirates (+971)
Uruguay (+598)
USA (+1) -->
Uzbekistan (+7)
Vanuatu (+678)
Vatican City (+379)
Venezuela (+58)
Vietnam (+84)
Virgin Islands - British (+1284)
Virgin Islands - US (+1340)
Wallis & Futuna (+681)
Yemen (North)(+969)
Yemen (South)(+967)
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The ongoing monthly CMO Moves series is outlining the relationship between pharmaceutical and biotech companies, and CMOs using recent news events and clinical trial catalysts. In this month’s edition, which covers events from late January to early March, manufacturing contract-related data from GlobalData’s PharmSource reports and news from GlobalData’s Pharma Intelligence Center have been collated to identify stakeholders at the center of new developments.
FDA and EMA decisions
In January, the European Commission (EC) approved Roche’s Xofluza (baloxavir marboxil) to prevent and treat influenza in children ages one year and older. Sharp Packaging Services is producing the solid dose of the drug and packaging it.
A few weeks later, the EC extended the approval label of AstraZeneca’s Forxiga (dapagliflozin) to include the treatment of symptomatic hearth failure. The SGLT2 inhibitor is already approved to treat type 2 diabetes (T2D), chronic kidney disease (CKD), and heart failure with reduced ejection fraction (HFrEF) in patients with or without T2D. Bristol Myers Squibb is in charge of the solid dose manufacturing, while Catalent is doing the solid dose production and packaging. SK Biotek is contracted to manufacture the small molecule API.
In early February, the FDA approved Regeneron Pharmaceuticals’ Eylea (aflibercept) injection to treat the rare disorder retinopathy of prematurity (ROP) in preterm infants. Vetter Pharma-Fertigung GmbH & Co KG is contracted for the parenteral manufacture and packaging for the vascular endothelial growth factor (VEGF) inhibitorvascular endothelial growth factor (VEGF) inhibitor, while Biogen and KBI Biopharma are producing the biologic API.
The US agency also extended the approval of Gilead Sciences’ Trodelvy (sacituzumab govitecan-hziy) to include the treatment of HR-positive HER2-negative breast cancerHER2-negative breast cancer patients after endocrine-based therapy and at least two systemic therapies. Samsung Biologics is producing the biologic API, while BSP Pharmaceuticals SpA is manufacturing the biologic API and the parenteral portions of the antibody-drug conjugate.
Preview
Source: Pharmaceutical Technology
Regulatory decisions by the FDA and EMA for select therapies from late January to late February and the CMOs contracted to manufacture the therapies.
Source: GlobalData Pharmaceutical Intelligence Center
Regulatory and reimbursement decisions in the UK
In late January, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) granted a marketing authorization to Beigene’s Brukinsa (zanubrutinib) to treat chronic lymphocytic leukemia (CLL) and marginal zone lymphoma (MZL) after at least one prior anti-CD20-based therapy. While Catalent is in charge of the solid dose manufacturing for the small molecule, PCI Pharma Services is responsible for solid dose manufacturing and packaging.
On February 1, the UK’s National Institute for Health and Care Excellence (Nice) published a recommendation to cover Daiichi Sankyo and AstraZeneca’s antibody-drug conjugate (ADC) Enhertu (deruxtecan) to treat HER2-positive metastatic breast cancer after one or more anti-HER2 treatments. Later that month, China’s National Medical Products Administration (NMPA) also granted an approval for the same indication. Baxter Biopharma Solutions is contracted for the parenteral manufacture and packaging of Enhertu.
Preview
Source: Pharmaceutical Technology
Regulatory decisions by the UK’s MHRA and NICE for select therapies from late January to late February and the CMOs contracted to manufacture the therapies.
Source: GlobalData Pharmaceutical Intelligence Center
Clinical trial catalysts
In late January, AC Immune released positive interim results from the Phase I/II trial (NCT05462106) studying the company’s vaccine in patients with prodromal Alzheimer’s disease. The vaccine ACI-24.060 elicited an anti-Abeta antibody response in the first patient cohort after six weeks, as per the results. Bachem Holding and Polymun Scientific Immunbiologische Forschung GmbH are contracted for the parenteral manufacturing, while WuXi Biologics Caymanis producing the biologic API.
In the same time period, Warren, New Jersey-based Tevogen Bio released positive data from a trial evaluating its allogeneic T cell therapy TVGN 489, which is meant to treat high-risk COVID-19. The study was conducted at Thomas Jefferson University Hospital in Philadelphia evaluated the therapy in 12 ambulatory patients. BioCentriq is contracted to manufacture the biologic API.
Preview
Source: Pharmaceutical Technology
Clinical trial catalysts announced for select therapies from late January to late February and the CMOs contracted to manufacture the therapies.
Source: GlobalData Pharmaceutical Intelligence Center
To read the previous editions in this series, click here, and here.
Free Report
How is the Biopharmaceutical industry evolving?
2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape.
GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects.
Access the report to:
Benchmark the impact of major themes on the Biopharmaceutical industry.
Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents.
Evaluate the effects of COVID-19 on the sector.
Download the full report to understand what to expect and how to align your strategies for success.
By GlobalData
Preview
Source: Pharmaceutical Technology
Submit
Country Code
UK (+44)
USA (+1)
Algeria (+213)
Andorra (+376)
Angola (+244)
Anguilla (+1264)
Antigua & Barbuda (+1268)
Argentina (+54)
Armenia (+374)
Aruba (+297)
Australia (+61)
Austria (+43)
Azerbaijan (+994)
Bahamas (+1242)
Bahrain (+973)
Bangladesh (+880)
Barbados (+1246)
Belarus (+375)
Belgium (+32)
Belize (+501)
Benin (+229)
Bermuda (+1441)
Bhutan (+975)
Bolivia (+591)
Bosnia Herzegovina (+387)
Botswana (+267)
Brazil (+55)
Brunei (+673)
Bulgaria (+359)
Burkina Faso (+226)
Burundi (+257)
Cambodia (+855)
Cameroon (+237)
Canada (+1)
Cape Verde Islands (+238)
Cayman Islands (+1345)
Central African Republic (+236)
Chile (+56)
China (+86)
Colombia (+57)
Comoros (+269)
Congo (+242)
Cook Islands (+682)
Costa Rica (+506)
Croatia (+385)
Cuba (+53)
Cyprus North (+90392)
Cyprus South (+357)
Czech Republic (+42)
Denmark (+45)
Djibouti (+253)
Dominica (+1809)
Dominican Republic (+1809)
Ecuador (+593)
Egypt (+20)
El Salvador (+503)
Equatorial Guinea (+240)
Eritrea (+291)
Estonia (+372)
Ethiopia (+251)
Falkland Islands (+500)
Faroe Islands (+298)
Fiji (+679)
Finland (+358)
France (+33)
French Guiana (+594)
French Polynesia (+689)
Gabon (+241)
Gambia (+220)
Georgia (+7880)
Germany (+49)
Ghana (+233)
Gibraltar (+350)
Greece (+30)
Greenland (+299)
Grenada (+1473)
Guadeloupe (+590)
Guam (+671)
Guatemala (+502)
Guinea (+224)
Guinea - Bissau (+245)
Guyana (+592)
Haiti (+509)
Honduras (+504)
Hong Kong (+852)
Hungary (+36)
Iceland (+354)
India (+91)
Indonesia (+62)
Iran (+98)
Iraq (+964)
Ireland (+353)
Israel (+972)
Italy (+39)
Jamaica (+1876)
Japan (+81)
Jordan (+962)
Kazakhstan (+7)
Kenya (+254)
Kiribati (+686)
Korea North (+850)
Korea South (+82)
Kuwait (+965)
Kyrgyzstan (+996)
Laos (+856)
Latvia (+371)
Lebanon (+961)
Lesotho (+266)
Liberia (+231)
Libya (+218)
Liechtenstein (+417)
Lithuania (+370)
Luxembourg (+352)
Macao (+853)
Macedonia (+389)
Madagascar (+261)
Malawi (+265)
Malaysia (+60)
Maldives (+960)
Mali (+223)
Malta (+356)
Marshall Islands (+692)
Martinique (+596)
Mauritania (+222)
Mayotte (+269)
Mexico (+52)
Micronesia (+691)
Moldova (+373)
Monaco (+377)
Mongolia (+976)
Montserrat (+1664)
Morocco (+212)
Mozambique (+258)
Myanmar (+95)
Namibia (+264)
Nauru (+674)
Nepal (+977)
Netherlands (+31)
New Caledonia (+687)
New Zealand (+64)
Nicaragua (+505)
Niger (+227)
Nigeria (+234)
Niue (+683)
Norfolk Islands (+672)
Northern Marianas (+670)
Norway (+47)
Oman (+968)
Palau (+680)
Panama (+507)
Papua New Guinea (+675)
Paraguay (+595)
Peru (+51)
Philippines (+63)
Poland (+48)
Portugal (+351)
Puerto Rico (+1787)
Qatar (+974)
Reunion (+262)
Romania (+40)
Russia (+7)
Rwanda (+250)
San Marino (+378)
Sao Tome & Principe (+239)
Saudi Arabia (+966)
Senegal (+221)
Serbia (+381)
Seychelles (+248)
Sierra Leone (+232)
Singapore (+65)
Slovak Republic (+421)
Slovenia (+386)
Solomon Islands (+677)
Somalia (+252)
South Africa (+27)
Spain (+34)
Sri Lanka (+94)
St. Helena (+290)
St. Kitts (+1869)
St. Lucia (+1758)
Sudan (+249)
Suriname (+597)
Swaziland (+268)
Sweden (+46)
Switzerland (+41)
Syria (+963)
Taiwan (+886)
Tajikstan (+7)
Thailand (+66)
Togo (+228)
Tonga (+676)
Trinidad & Tobago (+1868)
Tunisia (+216)
Turkey (+90)
Turkmenistan (+7)
Turkmenistan (+993)
Turks & Caicos Islands (+1649)
Tuvalu (+688)
Uganda (+256)
UK (+44) -->
Ukraine (+380)
United Arab Emirates (+971)
Uruguay (+598)
USA (+1) -->
Uzbekistan (+7)
Vanuatu (+678)
Vatican City (+379)
Venezuela (+58)
Vietnam (+84)
Virgin Islands - British (+1284)
Virgin Islands - US (+1340)
Wallis & Futuna (+681)
Yemen (North)(+969)
Yemen (South)(+967)
Zambia (+260)
Zimbabwe (+263)
Country
UK
USA
Afghanistan
Åland Islands
Albania
Algeria
American Samoa
Andorra
Angola
Anguilla
Antarctica
Antigua and Barbuda
Argentina
Armenia
Aruba
Australia
Austria
Azerbaijan
Bahamas
Bahrain
Bangladesh
Barbados
Belarus
Belgium
Belize
Benin
Bermuda
Bhutan
Bolivia
Bonaire, Sint Eustatius and Saba
Bosnia and Herzegovina
Botswana
Bouvet Island
Brazil
British Indian Ocean Territory
Brunei Darussalam
Bulgaria
Burkina Faso
Burundi
Cambodia
Cameroon
Canada
Cape Verde
Cayman Islands
Central African Republic
Chad
Chile
China
Christmas Island
Cocos Islands
Colombia
Comoros
Congo
Democratic Republic of
the Congo
Cook Islands
Costa Rica
Côte d"Ivoire
Croatia
Cuba
Curaçao
Cyprus
Czech Republic
Denmark
Djibouti
Dominica
Dominican Republic
Ecuador
Egypt
El Salvador
Equatorial Guinea
Eritrea
Estonia
Ethiopia
Falkland Islands
Faroe Islands
Fiji
Finland
France
French Guiana
French Polynesia
French Southern Territories
Gabon
Gambia
Georgia
Germany
Ghana
Gibraltar
Greece
Greenland
Grenada
Guadeloupe
Guam
Guatemala
Guernsey
Guinea
Guinea-Bissau
Guyana
Haiti
Heard Island and McDonald Islands
Holy See
Honduras
Hong Kong
Hungary
Iceland
India
Indonesia
Iran
Iraq
Ireland
Isle of Man
Israel
Italy
Jamaica
Japan
Jersey
Jordan
Kazakhstan
Kenya
Kiribati
North Korea
South Korea
Kuwait
Kyrgyzstan
Lao
Latvia
Lebanon
Lesotho
Liberia
Libyan Arab Jamahiriya
Liechtenstein
Lithuania
Luxembourg
Macao
Macedonia, The Former
Yugoslav Republic of
Madagascar
Malawi
Malaysia
Maldives
Mali
Malta
Marshall Islands
Martinique
Mauritania
Mauritius
Mayotte
Mexico
Micronesia
Moldova
Monaco
Mongolia
Montenegro
Montserrat
Morocco
Mozambique
Myanmar
Namibia
Nauru
Nepal
Netherlands
New Caledonia
New Zealand
Nicaragua
Niger
Nigeria
Niue
Norfolk Island
Northern Mariana Islands
Norway
Oman
Pakistan
Palau
Palestinian Territory
Panama
Papua New Guinea
Paraguay
Peru
Philippines
Pitcairn
Poland
Portugal
Puerto Rico
Qatar
Réunion
Romania
Russian Federation
Rwanda
Saint Helena, Ascension and Tristan da Cunha
Saint Kitts and Nevis
Saint Lucia
Saint Pierre and Miquelon
Saint Vincent and The Grenadines
Samoa
San Marino
Sao Tome and Principe
Saudi Arabia
Senegal
Serbia
Seychelles
Sierra Leone
Singapore
Slovakia
Slovenia
Solomon Islands
Somalia
South Africa
South Georgia and The South
Sandwich Islands
Spain
Sri Lanka
Sudan
Suriname
Svalbard and Jan Mayen
Swaziland
Sweden
Switzerland
Syrian Arab Republic
Taiwan
Tajikistan
Tanzania
Thailand
Timor-Leste
Togo
Tokelau
Tonga
Trinidad and Tobago
Tunisia
Turkey
Turkmenistan
Turks and Caicos Islands
Tuvalu
Uganda
Ukraine
United Arab Emirates
US Minor Outlying Islands
Uruguay
Uzbekistan
Vanuatu
Venezuela
Vietnam
British Virgin Islands
US Virgin Islands
Wallis and Futuna
Western Sahara
Yemen
Zambia
Zimbabwe
Kosovo
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