Recon: Sanofi expects EU determination on COVID booster inside weeks; FDA reviewers unconvinced forward of

Recon

| 06 September 2022 | By Joanne S. Eglovitch 

Welcome to Regulatory Reconnaissance, your day by day regulatory information and intelligence briefing.
 
In Focus: US

• FDA Lifts Maintain on Sarepta’s DMD Trial Following Protocol Changes (Biospace) (Fierce) (Pharma Letter)
• Up to date COVID boosters prepared in U.S. this week, White Home says (Reuters)
• FDA approves durvalumab for domestically superior or metastatic biliary tract most cancers (FDA) (Biospace)
• FDA expands approval for Vertex’s CF drug Orkambi to infants beneath two years of age (Endpoints) (The Pharma Letter)
• FDA once more finds Amylyx’s ALS knowledge missing forward of surprising second adcomm, whereas stressing dire want for therapies (Endpoints) (Pink Sheet) (Washington Publish)
• Two years after a refuse-to-file, Y-mAbs lands an FDA adcomm for its 2nd neuroblastoma therapy (Endpoints) (MedWatch)
• Alvotech fails pre-approval inspection for its proposed Humira interchangeable biosimilar (Endpoints)
• COVID-19 Vaccine Producers Urged To Make Labeling Adjustments To Keep away from Administration Errors (Pink Sheet)
• BARDA Proposes New Consortia For Speedy Pandemic Response (MedTech Perception)
• How Abbott Saved Sick Infants From Turning into a Scandal (NYT)

In Focus: Worldwide

• EU Regulator Eyes Mid-September For Resolution On Comirnaty BA.4/BA.5 Booster Approval (Pink Sheet)
• Sanofi sees EU regulatory determination on its COVID booster in weeks (Reuters)
• Enhance high-risk individuals with Omicron-tailored pictures first – EU officers (Reuters)
• EU swats down Illumina’s $8B Grail acquisition days after FTC misplaced antitrust case (Endpoints)
• EU blocks Illumina acquisition of Grail (MedWatch)
• Use of Gynecological Medicine Restricted In EU; ‘Pressing’ Security Assessment Begins For Pholcodine (Pink Sheet)
• Britain approves Pfizer/BioNTech’s up to date COVID-19 booster vaccine (Reuters)
• World Coalition Develops Constant Terminology To Help Decentralized Trials (Pink Sheet)
• Trial Sponsors Search New Nations As Russian Market ‘Falls Into The Abyss’ (The Pink Sheet)

Pharma & Biotech

• Biosimilar large Biocon will get hit with 483 for points at websites in Malaysia and India (Endpoints)
• RWE On The Runway: Trio Of Upcoming Approval Choices Will Take a look at US FDA’s Pondering On RWE For Efficacy (Pink Sheet)
• Lonza, Touchlight associate on ‘doggybone DNA’ growth (Fierce)
• BMS-backed Arsenal Bio pulls set off on $220M collection B, touting potential fleet of gene-edited cell therapies (Fierce)
• Iveric hits once more in pivotal eye illness program, protecting it on Apellis’ tail in race to market (Fierce)
• Synaffix rustles up one other ADC deal, allying with Emergence in $360M biobuck pact (Fierce)
• Aurobindo plugs $37M into biologics enlargement as its vaccine arm seems to be to get in on the contract manufacturing motion (Fierce)
• 5 Potential Blockbuster Oncology Approvals To Look Out For In 2023 (Scrip)
• Why India Pharma Failed To Impress In 2020-22 Bull Run (Scrip)

Medtech

• Federal jury convicts medtech govt in $77M blood testing kickback case (MedTech Dive) (MedTech Perception)
• Owkin AI for figuring out breast, colorectal most cancers sorts rating EU approval (Fierce)
• DEKRA Accredited To Audit In opposition to UKCA Marking, However Extra UK Capability Wanted (MedTech Perception)

Authorities, Regulatory & Authorized

• Philips settles with DOJ for $29M in 2 alleged False Claims Act violations (Bloomberg) (Fierce)
• Bayer to Pay $40 Million Over Whistle-Blower’s Bribe Claims (Bloomberg) (STAT)
• Otsuka and H. Lundbeck Sue Viatris Over Abilify Maintena Once more (FDAnews)
• Court docket win for United Therapeutics will restrain looming competitors for its soon-to-be blockbuster (Endpoints)
• J&J coughs up $40.5M in New Hampshire opioid settlement, evading upcoming trial (Endpoints)

Regulatory Recon is our day by day intelligence briefing for the regulatory affairs house, bringing you the highest regulatory, biopharma and medtech information tales from across the globe.
 
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