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

• 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)

• 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)
• 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)

• 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)

• 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)

• 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)

• 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)