Recon: J&J says booster increased COVID antibodies in early studies; Samsung boosts investment in biotech business

• Pentagon makes Pfizer vaccine mandatory after FDA approval- memo (Reuters)
• Moderna completes filing process for full approval of COVID-19 vaccine (Reuters)
• J&J says booster dose increased antibodies in early-stage studies (Reuters) (NYTimes)
• US data show rising 'breakthrough' infections among fully vaccinated (Reuters) (NYTimes) (STAT) (Politico)
• Limited Chinese cooperation hindering U.S. fentanyl fight -congress report (Reuters)
• U.S. COVID-19 vaccine approval is 'seismic' shift for legality of mandates, experts say (Reuters)
• Emergent's COVID-19 plasma therapy to be tested in NIH-sponsored study (Reuters)
• Diabetes screenings should start earlier for overweight adults, new guidelines say (NBC)

• COVID vaccine protection wanes within six months - UK researchers (Reuters)
• UK vaccine advisers to call for targeted booster programme (FT)
• Swiss agree deal with Pfizer for 14 million more COVID-19 vaccine doses (Reuters)
• Samsung to Invest $205 Billion in Chip, Biotech Expansion (WSJ)
• Sesen Bio pulls E.U. application for FDA-rejected cancer drug (STAT)
• EU approval for Rinvoq to treat atopic dermatitis (PharmaTimes)
• Africa has been shortchanged on Covid vaccines, African Development Bank says (CNBC)

• Seoul urges Biden to break vaccine IP deadlock (FT)
• Holes in reporting of breakthrough Covid cases hamper CDC response (Politico)
• Hot Spots Where Covid Vaccination Lags Push Experimental Antibody Treatment (KHN)
• Another Covid-19 antibody cocktail on the menu? Brii Bio touts early win in NIH study for a combo already used in China (Endpoints)
• US intel report on COVID-19 origins inconclusive: report (The Hill)

• Roche tees up $3B+ for Shape's RNA editing platform, with the bold promise of 'one-time' cures for Alzheimer's, Parkinson's (Endpoints)
• 10 ways to reform the FDA's accelerated approval pathway: ICER and MSKCC offer options (Endpoints)
• Is Ginkgo’s synthetic-biology story worth $15 billion? (MIT Technology Review)
• Rare disease drugmaker files for approval despite objections from FDA on adequate trial data (Endpoints) (Fierce)
• Vertex, looking to broaden its gene editing abilities, asks a young biotech for help (BioPharmaDive)
• With new results, J&J's $1B gamble on a targeted inflammation drug faces long odds (BioPharmaDive)
• Inside the 30-year hunt for the perfect antibody (Endpoints)
• PDUFA VII Communications: Earlier PMR Talks, Formal Meeting Additions (Pink Sheet)
• Immunocore's bispecific lands speedy review with FDA, EMA; Low-profile gene therapy player grabs $30M (Endpoints)
• J&J, Bayer's Xarelto scores FDA nod in post-surgery artery disease as partners try to catch up with Eliquis (Fierce)
• A Bristol Myers-backed biotech wants to treat heart disease with non-coding RNAs. It's one step closer to proof-of-concept (Endpoints)
• Merck's 15-strain flu shot matches Prevnar 13 in late-stage infant study, but Pfizer's next-gen shot looms (Endpoints)
• Takeda, CSL hereditary angioedema meds need steep discounts following real-world evidence review, ICER says (Fierce)
• New data bolster Regeneron's plan to defend top-selling eye drug (BioPharmaDive)
• Eli Lilly keeps its foot on dealmaking pedal, recruiting Carolyn Bertozzi's protein degradation tech for $1.6B+ (Endpoints)
• Alzheimer's biotech comes under attack as petition calls for trial halt, data audit — and it's fighting back (Endpoints)
• FibroGen, fresh off data manipulation scandal, touts win in cancer patients without revealing data (Endpoints)

• Intuitive Surgical responds to FDA notice against unauthorized use of robots in mastectomies (Fierce)
• Medtronic starts FY22 with electives boost, but delta hits in summer months (MedtechDive)
• Hospital volume recovery on shaky ground amid delta, Kaufman Hall reports (MedtechDive)
• FDA Panel Meeting To Focus On AI/ML Device Labeling, Transparency (MedtechInsight)

• Calif. Jury Clears C.R. Bard Over Design Of Vein Filter Implant (Law360)
• FTC, Illumina Clash On Merger's Potential To Win Cancer War (Law360)
• Glenmark Still Fighting To End DOJ Interviews Of India Execs (Law360)
• AbbVie's Humira Patent Claims Survive Dismissal Bid (Law360)
• J&J Must Face Ill. Pelvic Mesh Suit, 7th Circ. Says (Law360)
• Brazil Considers Easier Path For Compulsory Licensing (Pink Sheet)