Recon: Baxter in late-stage talks for $10B Hillrom buy; Catalent drops $1B for gummy vitamin maker
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
- COVID-19 Deaths And Hospitalizations Continue To Rise In The U.S. (NPR)
- HHS Lifts Pause on Lilly's Monoclonal Antibody Combo, Sort Of (MPT)
- U.S. CDC advisers vote in favor of Pfizer COVID-19 vaccine (Reuters)
- Baxter in late-stage talks to buy Hillrom for about $10B: WSJ (MedTech Dive)
- Reimbursement begins slowly for Biogen’s expensive Alzheimer’s drug (Endpoints)
- Biogen offers free Alzheimer's drug as Medicare payment uncertainty remains (Reuters)
- Demand Surges for Deworming Drug for Covid, Despite Scant Evidence It Works (NYT)
- FDA sees growing pressure to authorize vaccines for children under 12 (The Hill)
- CDC scientist says there’s limited data to evaluate Covid booster doses for general population (CNBC)
- India's COVID vaccine supply jumps, raising export hopes (Economic Times)
- China approves 6th home-grown anti-PD1 Mab (Pharmaletter)
- Japan's Moderna vaccine contamination woes (Reuters)
- EU recommends restrictions on US travelers amid COVID-19 spike (The Hill)
- WHO official in Europe says boosters not a 'luxury' (The Hill)
- Israel doubles down on booster shots as daily Covid cases set new record (CNBC)
- BioNTech looks at mRNA vaccine manufacturing options in Rwanda and Senegal (BioPharma Reporter)
- Australia establishes first national biotech incubator (BioPharma Reporter)
- People with delta variant twice as likely to be hospitalized: study (The Hill)
- South Africa detects new coronavirus variant, still studying its mutations (Reuters)
- COVID-19 vaccine maker AstraZeneca requires US employees to get vaccinated (The Hill)
- Revive Therapeutics reports progress with Phase III COVID-19 trial (Outsourcing Pharma)
- Quat disinfectants are helping during the pandemic. But could they contribute to antibiotic resistance? (C&EN)
- Inside Pfizer’s labs, ‘variant hunters’ race to stay ahead of the pandemic’s next twist (STAT)
- Pfizer ramps up its salesforce in battle of vaccine boosters (FT)
- Moderna founder's next big play in RNA raises $440M (BioPharma Dive)
- Catalent lays out $1B to buy gummy manufacturer Bettera, getting 4 factories and 500 new employees in the process (Fierce)
- Laronde Raises $440 Million to Further Advance New Class of Programmable Medicines (Rare Daily)
- Vertex boosts cell and genetic therapies toolkit in deal worth up to $1.2bn with Arbor (BioPharma Reporter)
- Lilly and Lycia Therapeutics enter into strategic collaboration to discover and develop novel lysosomal targeting chimera (LYTAC) degraders (PharmaNews)
- SPAC backs Revelation to tackle respiratory viral infections (Fierce)
- ESC 2021: Bayer's Kerendia touts outcomes data as it looks to complement J&J, AZ drugs (Fierce)
- ESC 2021: Bayer and Merck's Verquvo stakes its claim as a complementary heart failure treatment (Fierce)
- BI/Lilly's Jardiance Crowned As Heart Failure Game Changer After EMPEROR-Preserved (Scrip)
- Pfizer's abrocitinib beats blockbuster Dupixent in phase 3 eczema trial, but key questions remain (Fierce)
- CAR T therapy focused Umoja hits manufacturing capability linked milestone (BioPharma Reporter)
- Bone Therapeutics crashes as Phase III knee osteoarthritis study with JTA-004 fails (PharmaLetter)
- Brain cancer biotech Ziopharm snaps up new CEO from Kuur Therapeutics (Fierce)
- Flagship woos another Big Pharma BD exec to biotech. Red blood cell therapies anyone? (Endpoints)
- Hikma gains US rights to BAT2206, a proposed biosimilar to Stelara (Pharmaletter)
- Feng Zhang's lab develops potential breakthrough in RNA editing delivery using 'ultracompact' versions of Cas13 (Endpoints)
- COVID-19 seems to skew Abbott heart failure monitor study results (MedTech Dive)
- Boston Scientific's Watchman riskier for women, registry finds (MedTech Dive)
- How data-driven feedback in surgical robotics can help democratize access to surgery (MedCity News)
- Will Hearing Aids Ever Be Hip? (NYT)
- A Raman spectroscopy technique to reliably analyze hydrogels (EPR)
- Antidote Health nabs $12M in seed round to grow AI-driven virtual HMO (MedCity News)
- Former Theranos employees are still shaken as Elizabeth Holmes trial looms: ‘The fear is real’ (CNBC)
- Elizabeth Holmes plans to claim at trial ex-boyfriend and Theranos business partner abused her (CNBC)
- 4 ways Elizabeth Holmes could win over a jury (STAT)
- Founders of Taiwanese biotech involved in stealing Genentech secrets plead guilty to conspiracy (Endpoints)
- Philips sleep apnea, ventilator recall triggers US lawmaker scrutiny, legal woes (MedTech Dive)
- Opinion: Congress relying on flawed model to set drug pricing policy (Biocentury)
- At least 9 PDUFA dates on deck in September (Biocentury)
- No Comparison (Drug and Device Law)
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
