Recon: FDA authorizes Pfizer booster for 16 and 17 year olds; China approves Brii Biosciences’ COVID antibody

• FDA expands authorization for Pfizer’s Covid-19 booster to cover 16- and 17-year-olds (STAT) (FDA)
• AstraZeneca Covid-19 Antibody Authorized by FDA as Novel Tool to Prevent Symptomatic Disease (WSJ) (NYTimes) (FDA)
• U.S. campaign to vaccinate young children off to sluggish start despite abundant supply (Reuters)
• Becerra names incoming acting NIH director (The Hill)
• FDA panel turns down Reata kidney disease drug in unanimous vote (BioPharmaDive)
• Take a deep breath: Asthma drug study failed to include Black and Puerto Rican children who could benefit most (STAT)

• EU drugs regulator says data supports vaccine boosters after three months (Reuters)
• Intercept, awaiting needed trial data, pulls its NASH drug application in Europe (BioPharmaDive)
• China approves Brii Biosciences antibody COVID treatment (Reuters)
• After its $7.6B buyout fell through, Sobi scores NICE backing for rare disease drug Aspaveli (Fierce)
• German vaccine body recommends COVID shot for some under-12s (Reuters)
• Demand still strong for India-made AstraZeneca vaccine doses - COVAX's GAVI (Reuters)
• WHO warns against vaccine hoarding as poorer countries go without (Reuters)
• ‘Erratic’ European Covid vaccine donations hamper African jabs rollout (FT)

• Fresh data show UniQure's hemophilia gene therapy appears to hold up (BioPharmaDive)
• At biotech venture capital firms, collecting ‘consulting fees’ from startups has become widespread (STAT)
• RNAi drugs at “a remarkable period of a renaissance” (Nature)
• Promising to slim down and speed up, the ‘new’ J&J shakes up the executive committee ahead of the big split (Endpoints)
• Rare Chance Or Passing Opportunity: China Expands Orphan Drug Coverage With Steep Price Cuts (Pink Sheet)
• Taipei's Bora wants in on the CDMO game as report shows plenty of room for industry growth (Endpoints)
• Radius falters after a PhIII osteoporosis fail and a breast cancer disappointment, sending shares plummeting (Endpoints)
• Cingulate prices a downsized public offering as IPO party appears to die down (Endpoints)
• Struggling Aprea wins a reprieve as FDA lifts one of the holds on their only drug (Endpoints)
• Atlas, F-Prime launch K36 Therapeutics to advance oncology molecule for elusive epigenetic target (Endpoints)

• FDA floats independent contractor to track MDUFA hiring following medtech pressure (MedtechDive)
• Implantable cardioverter defibrillators are underused in women, racial minorities: study (MedtechDive)
• Study finds surgery volumes bounced back after 2020 COVID-19 shutdown, confirming medtech sales trends (MedtechDive)
• BD seals the deal to acquire UK-based surgical sealant maker Tissuemed (Fierce)
• Philips clinches FDA clearance for patient monitors that garnered emergency OK amid pandemic (Fierce)
• UK Consultation: Device Regulator Seeks To Balance Innovation And Patient Safety (MedtechInsight)

• Fed. Circ. Gives Mylan 2nd Chance To Ax AstraZeneca IP (Law360)
• House almost unanimously passes bipartisan bill to pump $500M into ALS drug R&D (Endpoints)