Recon: Baxter in late-stage talks for $10B Hillrom buy; Catalent drops $1B for gummy vitamin maker

ReconRecon | 30 August 2021 |  By 

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)
In Focus: International
  • 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)
Coronavirus Pandemic
  • 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)
Pharma & Biotech
  • 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)
Government, Regulatory & Legal
  • 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)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you