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The CDCs newly constituted Advisory Committee on Immunization Practices (ACIP) has voted to recommend the removal of vaccine preservative, thimerosal, that has become a focal point for activists trying to link vaccines to autism. Of all the issues the ACIP needs to focus on, this is not a big issue. The American people deserve no less."
The US Food and Drug Administration (FDA) has placed a clinical hold on several of Gilead’s trials evaluating two HIV treatment candidates, though the rest of the drugmaker’s diverse pipeline remains unaffected. Can pharma tariffs “Make America Manufacture Again”? Stay proactive with real-time data and expert analysis.
Bristol Myers Squibb (BMS) has announced that the US Food and Drug Administration (FDA) has given approval to label updates for its CAR T cell therapies, Breyanzi (lisocabtagene maraleucel; liso-cel) and Abecma (idecabtagene vicleucel; ide-cel) to treat multiple myeloma. Credit: Saiful52 / Shutterstock.
Madrigal accessed a large US market when it won accelerated US Food and Drug Administration (FDA) approval in March 2024 for the first MASH treatment in the region. Can pharma tariffs “Make America Manufacture Again”? If approved in Europe, Rezdiffra would have the same indication.
US Health Secretary Robert F Kennedy (RFK) Jr has appointed eight new members to the vaccine advisory panel at the Centers for Disease Control and Prevention (CDC), just days after firing the panel’s previous members in full. Can pharma tariffs “Make America Manufacture Again”? Credit: LightRocket via Getty Images. Who’s on the panel?
In a 2022 annual report, the US Food and Drug Administration’s (FDA) Office of Generic Drugs stated it had approved 106 first generics— the introductory generic competitors of branded drugs.
Manasi Vaidya June 18, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook BIO President John Crowley [L] speaking to US FDA Commissioner Dr Marty Makary [R] at the BIO International Convention in Boston. Can pharma tariffs “Make America Manufacture Again”? Data Insights The gold standard of business intelligence.
The FDA allows the production of these drugs if there are shortages of the brand equivalent. However, the US Food and Drug Administration (FDA) set deadlines for compounded production to end after Novo Nordisk bolstered its Wegovy supply chains and increased the drug’s availability. Sign up for our daily news round-up!
Robert Barrie June 18, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Priority review vouchers are often bought by companies looking to dramatically reduce FDA review time for a new drug application. The vaccine specialist stated its EBITDA will be positively impacted, with an update occurring when the transaction closes.
By GlobalData Learn more about Strategic Intelligence Zurzuvae, whose ownership rights will now transfer to Supernus, is the only US Food and Drug Administration (FDA)-approved pill to treat postpartum depression. Can pharma tariffs “Make America Manufacture Again”? Stay proactive with real-time data and expert analysis. in Q1 2025.
More than a century after an individual with type 1 diabetes was treated with insulin for the first time, the FDA approved Tzield, the first and only treatment to delay the onset of type 1 diabetes. The post Magazine: ‘Right shoring’ API production in Europe appeared first on Pharmaceutical Technology.
Find out more The transaction will see BioNTech assimilate its former rival in the Covid-19 vaccine arena. By GlobalData Learn more about Strategic Intelligence In July 2024, CureVac streamlined its focus towards oncology after selling influenza and Covid-19 vaccine development to GSK in a deal worth nearly €1.5bn.
In May 2021, the US Food and Drug Administration (FDA) published a draft industry guidance, ICH Q12: Implementation Considerations for FDA-Regulated Products. The FDA has also offered both early dialogue and training to share knowledge and experience with the industry, providing an excellent example for other regulators to follow.
It has already been speculated that AstraZenecas termination of a plan to invest £450 million in a new vaccine manufacturing plant in the UK came about in part because of the big increase in the VPAG rate for newer medicines from around 15% in 2024 and mid-single digits in the pre-pandemic era.
The US Food and Drug Administration (FDA) approved Amgen’s Blincyto (blinatumomab), the first bispecific T-cell engager (BiTE), in 2014 for adults with Ph- R/R B-ALL, with its label expanded in 2017 to include Ph+ and paediatric cases. Can pharma tariffs “Make America Manufacture Again”?
Recent US FDA data show that the lack of raw material availability contributes to 27% of drug shortages (see Appendix ). It is considered a moderate change by the FDA (CBE30) and NMPA. This change ranges from a moderate change (CBE-30) by the FDA to a minor change not requiring prior approval by the WHO.
Jaguar Gene Therapy is building a $125 million facility in RTP to manufacture adeno-associated virus (AAV)-based gene therapies, Beam Therapeutics is constructing an $83 million plant to develop precision medicines, and IQVIA, a CRO, opened an innovation lab in the park in 2021, focusing on bioanalytics, vaccines, biomarkers, and genomics.
She ranked 2nd on the “Most Powerful International Women” of Fortune Magazine 2019 edition Education: She holds a master’s degree in classics and modern languages from Oxford University Other Affiliations: Emma was appointed as Independent Director for Microsoft board in Dec’19. LinkedIn Total experience: 31 yrs.
ATMP facilities are different from conventional pharmaceutical facilities that process other traditional modalities, such as vaccines and monoclonal antibodies (mAbs), and often require heightened segregation and smaller footprints. FDA CFR Title 21 Parts 211, 600, and 1271; 8. , Complete Data Gathering.
The first mRNA drug (BNT162b2 vaccine) was granted emergency use authorization by the FDA in December 2020 and approved for marketing in August 2021. The first mRNA drug (BNT162b2 vaccine) was granted emergency use authorization by the FDA in December 2020 and approved for marketing in August 2021.
The findings suggest that there will be 30+ FDA new drug approvals in the next year, more than five commercial COVID vaccines – resulting in a production squeeze at CDMOs and consequentially higher margins and profits for supply side companies – with mRNA, advanced therapies.
Pfizer’s partnership with BioNTech is one example of what Forbes’ Magazine dubbed “ The Great Coronavirus Collaboration.” In response to the COVID-19, Pharma was forced to quickly pivot and explore new ways of working to act with urgency and a sense of responsibility.
The departure of the US Food and Drug Administration’s (FDA) cell and gene therapy director and deputy director fuels ongoing turbulence in the treatment modality’s sector and could lead to changes in safety monitoring for drugs, according to an investment analyst. Can pharma tariffs “Make America Manufacture Again”?
MSD has received US Food and Drug Administration (FDA) approval for its anti-programmed death receptor-1 (PD-1) therapy, Keytruda (pembrolizumab), for adults with resectable locally advanced head and neck squamous cell carcinoma (HNSCC). Can pharma tariffs “Make America Manufacture Again”? Credit: Katherine Welles/Shutterstock.
Indian pharma group Wockhardt has completed a pre-filing meeting with the FDA and hopes to submit its new antibiotic Zaynich in the US and Europe later this year, eyeing a possible launch in fiscal 2026/27.
Sarepta stated the event has been reported to the US Food and Drug Administration (FDA) and global health authorities. Can pharma tariffs “Make America Manufacture Again”? Roche and Sarepta jointly manage the clinical studies for Elevidys. The companies did not release further details on the second death.
Both the development of COVID-19 vaccines and monoclonal antibody therapies and supply chain shortages related to the pandemic have affected sup-ply of the essential filters and chromatography resins used in the manufacture of biological products. This approach is aligned with guidance presented recently by the FDA. 7 Hoath, C.,
BIO 2025 this year came at a uniquely fraught moment for vaccination in the United States just days after HHS Secretary Robert F Kennedy Jr. BIO 2025 this year came at a uniquely fraught moment for vaccination in the United States just days after HHS Secretary Robert F Kennedy Jr. The economics are there.
Robert Barrie June 13, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook mRESVIA is the second approved product in the US for Moderna, along with its Covid-19 vaccine Spikevax. Until now, the vaccine was licensed for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 years and older.
George Merck on the cover of Time magazine. The FDA’s Frances O Kelsey: by blocking approval of Thalidomide in the US, Kelsey prevented thousands of children being born with life-changing deformities. Photo: FDA. Thalidomide and the development of drug safety regulation and monitoring.
Scientific experts are concerned about what role vaccines will play in US public health strategy under the Trump administration. Robert Barrie June 25, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook RFK Jr has embarked on a mission to reset vaccine regulation and evidence generation in the US.
Robert Barrie and Ross Law June 10, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The removal ACIP members marks the most significant upheaval to the current vaccine landscape under Trump’s administration. Can pharma tariffs “Make America Manufacture Again”? lev radin via Shutterstock. lev radin via Shutterstock.
A shortage of a commercially available drug is one of the criteria that allows compounded production, according to FDA legislation. No news is good news” Matters have been complicated by recent FDA legislation that requires compounders to stop producing versions of semaglutide and tirzepatide as both drugs are no longer in shortage.
A separate executive order, the implementation of which has been less clearly explained by the administration, is one signed on 5 May that will direct the US Food and Drug Administration (FDA) to prioritise approval of domestic facilities. Can pharma tariffs “Make America Manufacture Again”?
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