Regulatory Focus™ > News Articles > 2021 > 4 > Recon: Pfizer, BioNTech seek to extend vaccine to ages 12-15; Deficiencies flagged in Provention dia

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Posted 09 April 2021 | By Michael Mezher 

Recon: Pfizer, BioNTech seek to extend vaccine to ages 12-15; Deficiencies flagged in Provention diabetes drug application

2768 Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Pfizer, BioNTech request expanded emergency use of Covid-19 vaccine for ages 12-15 (CNBC)
  • Biden’s Orphaned AstraZeneca Stockpile Grows to 20 Million Doses (Bloomberg)
  • Scientists work toward an elusive dream: a simple pill to treat Covid-19 (STAT)
  • Biden pushes Congress to boost public health, pandemic preparedness funding (STAT)
  • Inside the White House’s push for a new, $6.5 billion agency aimed at curing cancer (STAT)
  • Provention Bio latest drugmaker flagged for 'deficiencies' in FDA approval application (BioPharmaDive) (Pink Sheet) (Endpoints)
In Focus: International
  • EU reviews J&J COVID-19 vaccine for blood clots, expands AstraZeneca probe (Reuters)
  • Europe's vaccine drive set to pick up as 100 millionth dose delivered (Reuters)
  • AstraZeneca cuts this week’s vaccine deliveries to EU by half (FT)
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  • EU preparing orders for 1.8 billion vaccine booster shots - Die Welt (Reuters)
  • J&J says in talks with Indian government for trial of single-dose vaccine (Reuters)
  • French health body to say mRNA vaccine should be used as second dose after AstraZeneca (Reuters)
  • Russia says Sputnik V dispute with Slovakia won't undermine EU confidence (Reuters)
  • Germany has started talks for Sputnik V vaccine - health minister (Reuters)
  • Russia says it records no deaths linked to its coronavirus vaccines (Reuters)
  • Russia says Sputnik shot less effective vs S.Africa variant but better than others-Ifax (Reuters)
  • Lack of vaccine capacity propels Canada into global race to attract drug companies (Politico)
Coronavirus Pandemic
  • Countries emphasise importance of AstraZeneca shot as they look to alternatives (Reuters)
  • COVAX says India's Serum Institute bound to supply virus vaccines (Reuters)
  • From Vaccine Nationalism to Vaccine Equity — Finding a Path Forward (NEJM)
  • African Union halts AstraZeneca vaccine purchases over supply concerns (FT)
  • UK 'depends practically entirely' on Europe for COVID-19 vaccines - EU's Breton (Reuters)
  • Australia doubles Pfizer vaccine order as Astra clotting worries upend rollout (Reuters)
  • Italy could sign contract with Moderna for more vaccine doses – paper (Reuters)
  • Indonesia turns to China for more vaccines after AstraZeneca delays (Reuters)
  • Hong Kong government to delay imports of AstraZeneca vaccine amid safety concerns (Reuters)
  • China repeats call to resist 'vaccine nationalism', pledges to keep monetary support (Reuters)
  • FDA Recommends Transition from Use of Decontaminated Disposable Respirators - Letter to Health Care Personnel and Facilities (FDA)
Pharma & Biotech
  • Biogen adds a late-stage prospect to its growing biosimilar business (BioPharmaDive)
  • With new data, Merck could be first to bring immunotherapy to early kidney cancer (BioPharmaDive)
  • Brazilian judge temporarily suspends pharmaceutical patent extensions amid push to lower drug costs (STAT)
  • Natural killer cells, primed with an antibody, induce remissions in patients with advanced blood cancer (STAT)
  • Novartis MS therapy gains MHRA and EC approval (PharmaTimes)
  • NICE 'no' for Opdivo/Yervoy lung cancer combo (PharmaTimes)
  • Opdivo improves survival in oesophageal cancer (PMLive)
  • The COVID Boom: CBER Receives More INDs in One Quarter Than The Previous 30 Combined (Pink Sheet)
  • Sanofi drops 'intriguing' data on rival to Bristol Myers' bempeg (Fierce)
  • Werewolf Therapeutics looks to make a killing in the public markets with a $100M IPO (Fierce)
  • Laying claim to another AI 'first,' Exscientia tees up an I/O drug for the clinic (Endpoints)
  • EU nod for new formulation of Biogen's Tysabri (PharmaTimes)
  • John Robinson recruits a small band of Array vets to kickstart discovery at Cogent; Syntimmune co-founder takes charge at Arch Oncology (Endpoints)
  • Ferring, Blackstone’s $570M gene therapy venture has imploded after CMC issues stymied a once high-profile quest (Endpoints)
  • CDMO Sterling acquires ADC Bio, ramping up capacity for antibody-drug conjugate manufacturing work (Endpoints)
  • AACR: Germany's small NK cell player Affimed makes a big splash with early lymphoma data (Endpoints)
  • The numbers are in, and new Vertex CEO Reshma Kewalramani took home half of what predecessor Jeff Leiden did in his last year on the job (Endpoints)
  • MPM-backed Werewolf, Merck-partnered Artiva make quick IPO flip while Luca Santarelli's biotech raises $127.5M (Endpoints)
  • Can he pick them? A high-profile Wall Street analyst jumps into biotech as CFO of an oncology upstart (Endpoints)
  • Industrializing engineered autologous T cells as medicines for solid tumours (Nature)
Medtech
  • Donisi scores FDA clearance for contactless AI system that spots changes in heart, breathing patterns (Fierce)
  • How MDR Delay And Grace Period Expansion Saved Medtech, But Why Another Crisis Looms (MedtechInsight)
  • Medtronic's robotic spine market lead threatened as smaller rivals look to edge in (MedtechDive)
  • Hologic pens $795M Mobidiag buyout to expand in acute care testing (MedtechDive)
  • TransMedics' 'heart in a box' donor organ preservation system scores FDA panel backing (Fierce)
  • Orthopaedic surgeons see slow volume recovery from COVID-19, tip Stryker to gain in poll (MedtechDive)
Government, Regulatory & Legal
  • FDA Letters Suggest Scrutiny Of Virus And Vaping Products (Law360)
  • Lab Supplier Says Wrong Co. Sued Over Faulty COVID Tests (Law360)
  • Outdated Experts Doom Suit Tying Diabetes Drug To Cancer (Law360)
  • Full Fed. Circ. Told Newer Amgen Drug Patent Was 'Trivial' (Law360)
  • Motion to Dismiss Denied in Amgen v. Hospira BPCIA (Big Molecule Watch)
  • Purdue Wants Another Month's Reprieve From Opioid Suits (Law360)
  • Opioid Judge Withdraws After AbbVie Elevates His Atty Sister (Law360)
  • 9th Circ. 'Directly Supports' Zetia Class Fight, 4th Circ. Told (Law360)
  • Right on Warnings in Texas, Not So Much on the Rest (Drug & Device Law)
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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