Regulatory Focus™ > News Articles > 2021 > 6 > Recon: Morphosys to buy Constellation Pharma in $1.7B deal; US begins study to mix-and-match COVID v

Recon: Morphosys to buy Constellation Pharma in $1.7B deal; US begins study to mix-and-match COVID vaccine boosters

Posted 02 June 2021 | By Michael Mezher 

Recon: Morphosys to buy Constellation Pharma in $1.7B deal; US begins study to mix-and-match COVID vaccine boosters

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • US to detail global distribution plan for 80M vaccine doses (Reuters)
  • US begins study testing mix-and-match Covid vaccine booster shots (CNBC)
  • Moderna bags another US CDMO to help with fill-finish work for its vaccine amid booster push (Endpoints)
  • Moderna plans mix of COVID-19 vaccine doses with new Lonza deal (Reuters)
  • AbbVie's Skyrizi takes home a win in late-stage Crohn's study, adding some heft to its expansion plans (Endpoints)
  • Novartis stakes another PhIII win for Cosentyx, goes deeper into pediatric markets (Endpoints) (Press)
In Focus: International
  • CanSinoBIO's inhalation COVID-19 shot in mid-stage trial, says CEO (Reuters)
  • German drug maker Morphosys to buy Constellation Pharma in $1.7 billion deal (STAT)
  • Australia, Spain, Sweden among nations to announce fresh COVAX donations (Reuters)
  • Germany to build up reserve vaccine capacity to fight future pandemics (Reuters)
  • AstraZeneca says working with governments to boost COVAX donations (Reuters)
  • Japan to donate additional $800 mln, vaccines to WHO's COVAX body – media (Reuters)
  • Britain seeks extra AstraZeneca shots to combat ‘beta’ COVID-19 variant (Reuters)
  • ‘A perilous point’: Global agencies call for $50 billion investment to combat Covid-19 (STAT)
Coronavirus Pandemic
  • Anthony Fauci’s pandemic emails: ‘All is well despite some crazy people in this world’ (Washington Post)
  • Israel sees probable link between Pfizer vaccine and myocarditis cases (Reuters)
Pharma & Biotech
  • Novartis plots 'next frontier' of MS treatment — and it could spell a buyout for a small Swiss player (Endpoints)
  • Novartis calls off 3 Beovu trials testing more frequent dosing on concerns of vision-threatening side effect (Fierce)
  • US FDA Action On Regenerative Medicine May Be Hindered If Court Sides With Stem Cell Clinics (Pink Sheet)
  • Can’t Wait to See You! Will CDER Soon Resume In-Person Meetings? (FDA Law Blog)
  • Sanofi rare disease drug hits another setback (BioPharmaDive)
  • Scynexis clinches FDA green light for vaginal yeast infection blockbuster-to-be (Fierce)
  • NICE rejects risdiplam for treating spinal muscular atrophy (Pharmafile)
  • Months after axing a Duchenne program and laying off dozens, Santhera claims a win there with a different program (Endpoints)
  • Immunovant flashes secret data behind potential Roivant buyout, but investors see a difficult future (Endpoints)
  • Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) Plus Yervoy (ipilimumab) as First-Line Treatment for Unresectable Malignant Pleural Mesothelioma (Press)
  • Genmab enlists another antibody conjugate partner, teaming up with Bolt to develop up to 3 cancer programs (Endpoints)
  • After taking a look at new data, regulators put J&J's BCMA/CD3 bispecific on a 'breakthrough' track (Endpoints)
  • Broad Institute's Eric Lander confirmed to Biden cabinet; Legend reveals the BCMA CAR-T data package behind priority review (Endpoints)
  • Almost a decade after identifying a new class of RNA, a group of scientists sparks interest from Takeda Ventures (Endpoints)
  • A simple patient survey revolutionized ALS drug development in the 1990s. Its creator says it may be time for an upgrade (Endpoints)
  • Manufacturing and Use of Cannabis-Derived Drugs Should Be Permitted: MHLW Panel (PharmaJapan)
Medtech
  • With new CEO, Veracyte outlines €260M deal for French test maker HalioDx and global cancer testing expansion (Fierce)
  • Abiomed acquires preCARDIA and its catheter-based system to treat heart failure (Fierce)
  • Acutus Builds On Arrhythmia Mapping Success With New Ablation Devices (MedtechInsight)
  • Guardant Health, Roche’s Foundation Medicine Receive FDA Companion Diagnostic Nods (MedtechInsight)
Government, Regulatory & Legal
  • GlaxoSmithKline scores a big win in Zofran litigation after FDA repeatedly rejects pregnancy warning (Fierce)
  • Calif. Doc Can't Force CVS To Fill Opioid Prescriptions (Law360)
  • Key Ruling Foils GSK Zofran MDL Ahead Of Bellwether (Law360)
  • Clarus Wins Ax Of Rival's Testosterone Patent Claims (Law360)
  • Sanofi Urges 10th Circ. To Revive EpiPen Antitrust Case (Law360)
  • FTC's Illumina-Grail Court Case Dropped Despite Cos.' Protest (Law360)
  • AbbVie Asks Justices To Hear Sham Litigation Exception Case (Law360)
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.

 

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Tags: global, US

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