Regulatory Focus™ > News Articles > 2021 > 9 > Recon: BioNTech to seek approval for vaccine in children ages 5-11; Biden orders sweeping new vaccin

Recon: BioNTech to seek approval for vaccine in children ages 5-11; Biden orders sweeping new vaccine mandates

Posted 10 September 2021 | By Michael Mezher 

Recon: BioNTech to seek approval for vaccine in children ages 5-11; Biden orders sweeping new vaccine mandates

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • FDA says robust safety data needed before COVID-19 vaccine approval for kids (Reuters) (FDA)
  • Attacking anti-vaccine movement, Biden mandates widespread COVID shots, tests (Reuters) (NYTimes) (AP)
  • Senate considers pegging Medicare drug prices to deeply discounted Veterans Affairs rates (STAT)
  • Martin Shkreli to go toe-to-toe with new FTC chair over Daraprim price spikes (Endpoints)
  • Bausch to pay $300M in antitrust suit over diabetes drug (Reuters)
  • Endo Strikes $50M Opioid Deal In NY Amid Trial Tumult (Law360)
In Focus: International
  • BioNTech to seek approval soon for vaccine for 5-11 year olds-Spiegel (Reuters)
  • UK prepares for ‘mix and match’ Covid vaccine booster programme (FT)
  • Lung cancer patients in England to receive Amgen drug that targets a gene mutation (Reuters)
  • Vietnam approves Hayat-Vax coronavirus vaccine for emergency use (Reuters)
  • Sinovac in talks about setting up South Africa vaccine production (Reuters)
  • EU rejects reworking N. Ireland deal, urges rhetoric dial-down (Reuters)
  • Aspen Gets Unsolicited Offers for Pharma Ingredient Unit (Bloomberg)
Coronavirus Pandemic
  • Germany recommends COVID-19 vaccinations for pregnant women (Reuters)
  • Pfizer accused of holding Brazil ‘to ransom’ over vaccine contract demands (The Guardian)
  • ECMO Life Support Is a Last Resort for Covid, and in Short Supply in South (KHN)
  • Increase in manufacturing capacity for COVID-19 vaccine from BioNTech/Pfizer (EMA)
Pharma & Biotech
  • Thermo Fisher, as part of global expansion plans, outlines new single-use site in Nashville (Endpoints)
  • Apellis turns up mixed results in closely watched eye disease tests. Are the data strong enough for approval? (Endpoints) (STAT)
  • England’s NICE To Find New Chief As Leng Announces Retirement (Pink Sheet)
  • Recro takes on big brother role with opioid addiction drug maker, handling manufacturing duties and advising on FDA work (Endpoints)
  • Biomanufacturer Raw Material Control on Regulatory Front Burner as Analytical Power and Formulation Challenges Intensify (IPQ)
  • Flagship keeps ex-FDA commish Stephen Hahn busy with another CMO gig; Daphne Koller makes key hire at insitro by welcoming Google and Facebook vet (Endpoints)
  • Not just the approved indications: FDA to study DTC drug ads that include secondary endpoint data (Endpoints)
  • NICE OKs Xeljanz for individuals with juvenile idiopathic arthritis (PharmaTimes)
  • Ixaka’s cell therapy clears early phase 3 data review (Fierce)
  • Researcher warned by FDA after failing to submit data 3 years after trial completion (Endpoints) (STAT)
  • FDA grants Fast Track Designation for Vor Biopharma’s AML drug (Pharmafile)
  • Chinese Biotech Sector Regains Mojo As Listings, Funding Deals Inject $357m (Scrip)
  • IPO filings are back on the biotech menu as an ADHD drug developer submits its Nasdaq paperwork (Endpoints)
  • After decade-plus of failures, AstraZeneca finally gets a win for storied immunotherapy (kind of) (Endpoints)
  • Vector Labs decouples from Maravai, popping up shop with private capital, new CEO on board (Endpoints)
  • AstraZeneca amends license deal with Chinese biotech; Chinese protein-based vaccine gets manufacturing OK (Endpoints)
  • FDA ends summer with fresh batch of breakthrough device designations (MedtechDive)
  • Roche ties the knot with long-time testmaking partner TIB Molbiol after COVID successes (Fierce)
  • Novocure scores breakthrough label for liver tumor-treating electric fields and plans Avastin, Tecentriq combo studies (Fierce)
  • Why The New EU Medtech Regulations Have Caused Chaos And Concern For Combination Products (MedtechInsight)
Government, Regulatory & Legal
  • F.D.A. Delays Decision on Juul’s E-Cigarettes but Orders Others Off the Market (NYTimes) (Reuters) (Politico)
  • Jury Hands CR Bard A Win In Ohio Hernia Mesh Bellwether (Law360)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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