Regulatory Focus™ > News Articles > 2021 > 10 > Recon: FDA approves Lilly's Verzenio for early breast cancer; Ebola vaccination campaign begins in C

Recon: FDA approves Lilly's Verzenio for early breast cancer; Ebola vaccination campaign begins in Congo

Posted 13 October 2021 | By Michael Mezher 

Recon: FDA approves Lilly's Verzenio for early breast cancer; Ebola vaccination campaign begins in Congo

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Data suggests mRNA booster dose generates stronger antibody response after J&J shot – Axios (Reuters)
  • Relying on J&J's analyses to assess vaccine booster dose data -U.S. FDA staff (Reuters) (NYTimes)
  • US FDA staff says Moderna did not meet all criteria for COVID-19 boosters (Reuters)
  • Vaccine requirements raised COVID-19 vaccination rates by 20 percentage points -White House (Reuters)
  • White House tells states to prepare for Covid vaccinations in young children (CNBC)
  • Purdue Pharma judge to rule on bid to pause opioid deal Wednesday (Reuters)
  • Aspirin use to prevent first heart attacks not recommended for most older adults -U.S. panel (Reuters)
  • Eli Lilly bags FDA nod for Verzenio in early breast cancer, but a controversial diagnostic could dog its rollout (Endpoints)
In Focus: International
  • Roche says Ocrevus drug reduces need for walking aids for MS patients (Reuters)
  • 'Virtually painless' needle-free injections developed in Netherlands (Reuters)
  • Russia to test COVID-19 vaccine in form of nasal spray (Reuters)
  • Big Health scores a novel deal to bring its digital therapeutics to an entire country (STAT)
  • Takeda takes aim at a biotech's gene therapy work (BioPharmaDive)
  • Ebola vaccination campaign begins in Congo after virus resurfaces (Reuters)
  • Russia says Sputnik Light is 70% effective against Delta variant (Reuters)
  • EU may consider deal on Merck's COVID pill after approval procedure begins -source (Reuters)
Coronavirus Pandemic                                                                                                                                       
  • WHO says it may be 'last chance' to find COVID origins (Reuters)
  • Russia, EU to discuss terms for recognising COVID-19 vaccine certificates -Ifax (Reuters)
  • House COVID-19 panel questioning Deborah Birx (The Hill)
  • Provisional determination granted to Pfizer's COVID-19 vaccine (COMIRNATY) - proposed for use in children 5-11 years of age (TGA)
Pharma & Biotech
  • GSK tangoes with private equity players to explore $54B sale of consumer unit instead of IPO — report (Endpoints)
  • As TRIPS council meets, the IP waiver for vaccines is on life support ahead of a December deadline (Endpoints)
  • FDA’s Advanced Manufacturing Initiatives Helping to Provide Quality Human Drugs for Patients (FDA)
  • Treating autism through the gut? Axial Therapeutics refuels on its exploration of the gut-brain axis (Endpoints)
  • Spurned by the FDA, Ardelyx execs grab bonuses to stay on while axing nearly two-thirds of remaining staff (Endpoints)
  • CRISPR Therapeutics claims safety advantage in first big look at off-the-shelf CAR-T data, but durability in question (Endpoints) (STAT)
  • Bristol Myers Squibb engaged in Acceleron buyout talks but couldn't justify the price: report (Fierce)
  • Intellia enters Editas’ turf with ocular CRISPR pact (Endpoints)
  • Big Pharma companies join hands with Amazon on new Israel-based AI incubator (Endpoints)
  • Drawn to the idea of turning B cells into 'protein factories,' Takeda jumps into a milestone-heavy, $900M pact (Endpoints)
  • Charles River Laboratories has been on an acquisition spree. But Tuesday, it offloaded two assets (Endpoints)
  • Regulus dumps first-gen ADPKD treatment in favor of second iteration; Sutro joins BioNova in $200M deal (Endpoints)
  • Olympus investigating ‘potential cybersecurity incident’ on American IT systems, its second in a month (Fierce)
  • Dexcom plots course to bring real-time blood glucose data to Garmin fitness devices (Fierce)
  • Abbott, Dexcom could benefit from CGM use jump among Type 2 diabetes patients: report (MedtechDive)
  • Chinese Volume-Based Procurement Pilot Hits Medtech Stock Prices (MedtechInsight)
  • EN ISO 13485 and EN ISO 14971: Next Wave Of EU Standards Now Due “By December” (MedtechInsight)
  • Withings gets FDA nod for AFib-detecting wearable, taking on Apple (MedtechDive)
  • Potential Risk of Infection When Using Heater-Cooler Devices – Letter to Health Care Providers (FDA)
  • Delphinus receives FDA clearance for ultrasound breast cancer screening tech (MobiHealthNews)
Government, Regulatory & Legal
  • Insurer Accuses Jazz Pharma Of 'Grotesque' Antitrust Scheme (Law360)
  • US Appellate Court Hands Siemens Big Win In False Advertising Suit (MedtechInsight)
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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