Recon: J&J says booster increased COVID antibodies in early studies; Samsung boosts investment in biotech business
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- 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)
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