Regulatory Focus™ > News Articles > Regulatory Recon: Novartis to Buy French Drugmaker AAA for $3.9B; Merck Withdraws EU Application for

Regulatory Recon: Novartis to Buy French Drugmaker AAA for $3.9B Merck Withdraws EU Application for Keytruda in NSCLC (30 October 2017)

Posted 30 October 2017 | By Michael Mezher 

Regulatory Recon: Novartis to Buy French Drugmaker AAA for $3.9B Merck Withdraws EU Application for Keytruda in NSCLC (30 October 2017)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • CVS-Aetna Deal Could Mean End of Era in How Drugs Are Paid For (Bloomberg)
  • Hearing Amazon's Footsteps, the Health Care Industry Shudders (NYTimes)
  • Eagle Pharma gets tentative FDA approval for Lilly's Alimta version (Reuters) (Press)
  • AbbVie surprises with solid earnings, priority review for endometriosis med (Fierce)
  • Trump fumes at drug makers for many reasons. This pharma exec (and Trump donor) embodies them (STAT)
  • How FDA Should Use Its Authority to Regulate Human Cells (The Regulatory Review)
  • Drugging The Undruggable: Kymera's Targeted Protein Degradation (Forbes)
  • Half Of Patients With Super-High Cholesterol Can't Get Drugs That Could Help (Forbes)
  • Merck: Cyberattack Caused $135M in Lost Sales (Focus)
  • Opioid epidemic shares chilling similarities with past drug crises (AP)
  • Opioids on the Quad (NYTimes)
  • In pro-Trump Ohio county, opioid announcement disappoints (Reuters)
  • Investor group presses US drug companies on opioid controls (Reuters)               
  • Synthetic Fentanyl Deaths Rise in Americans Opioid Epidemic (NBC)

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In Focus: International

  • Novartis announces $3.9bn deal for French drugmaker AAA (Financial Times) (Endpoints) (Reuters) (NYTimes) (Press)
  • Merck withdraws key European application for Keytruda (Financial Times) (Reuters)
  • AstraZeneca licenses genetic disease drug to Mereo BioPharma (Reuters) (Financial Times) (Fierce)
  • Fosun Pharmaceutical to buy French drug distributor Tridem (Financial Times)
  • Shire to make genetic disease drug itself to secure supply (Reuters)
  • German drug regulator finds dirty rooms in Dr' Reddy's facility (Economic Times)
  • UK pharma contributes £190m to NHS meds bill (PharmaTimes) (ABPI)
  • UK pharma trade group receives more complaints about its members (STAT) (PharmaTimes)
  • WHO report signals urgent need for greater political commitment to end tuberculosis (WHO)
  • Samsung reinforces biologic manufacturing, development partnership with MSD (Pharmafile)
  • EU regulators to review Sandoz' Neulasta biosimilar (PharmaTimes)
  • EMA's Proposal To Disclose Key Elements Of Pediatric Plans On Hold For Now (Pink Sheet-$)
  • Brexit Already Affecting UK Regulator's Role In Marketing Authorizations (Pink Sheet-$)
  • Drugmaker Endo's third-quarter earnings forecast tops estimates (Reuters)
  • Gilead Exec: How To Cure An Infectious Disease In The World's PoorestCountries (Forbes)

Pharmaceuticals & Biotechnology

  • FDA updates on 2017 Burkholderia cepacia contamination (FDA)
  • FDA Describes New GDUFA II User Fee Structure (Focus) (Lachman Consultants)
  • The top 20 rare disease specialists spotlight key biotech trends behind the boom (Endpoints)
  • Vaxart reverse merges its way onto Nasdaq, climbing aboard the Aviragen shell (Endpoints)
  • In a strategic switch, Sumitomo Dainippon bags rights to a PhIII diabetes drug from Poxel in $300M deal (Endpoints)
  • Puerto Rico's Pharma Industry: How Long Can It Wait For An Operational And Reliable Electrical Grid? (Forbes) (The Street)
  • Infections And Deaths Mount In Puerto Rico As Hurricane-Related Risks Continue (Forbes)
  • Real World Evidence Benefits, Limits Explored In US FDA Demonstrations (Pink Sheet-$)
  • Biosimilar Global Reference Standard Intrigues US FDA, But Many Questions Still To Answer (Pink Sheet-$)
  • Michael J. Fox Foundation partners with 23andMe for precision medicine project on Parkinson's (STAT)
  • Switching Crohn's patients to biosimilar Inflectra from Remicade is safe and effective, Pfizer says (Pharmafile) (Press)
  • Atlas, Amgen, Lilly back Kymera's $30M series A (Fierce)
  • Insys founder resigns from board after charges in US opioid bribe case (Reuters)
  • Landmark gene therapy poised for US approval (Nature)
  • $215 million cancer immunotherapy biomarker consortium debuts (Nature)
  • Richard Lehman's journal reviews—30 October 2017 (BMJ)
  • Aerie names Allergan veteran John Maltman VP of medical affairs (Fierce)
  • Astellas Enters into a Screening Collaboration Agreement with MMV to Discover Antimalarial Drugs (Press)
  • Is Triple Phase III Triumph for AbbVie's Risankizumab In Psoriasis Good Enough? (SCRIP-$)
  • Bloodied Celgene posts promising ozanimod PhIII MS data, but is it really a $6 billion drug? (Endpoints)
  • Atlas-incubated Kymera leaps out of stealth mode, joins the hunt for game-changing protein degradation drugs (Endpoints)
  • Buprenorphine Injectable Opioid Abuse Treatment: Will REMS Prevent Misuse? (Pink Sheet-$)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • FDA Approves New 10 mg Dosing for XARELTO® (rivaroxaban) to Reduce the Continued Risk of Venous Thromboembolism (VTE) (Press)
  • European Medicines Agency Validates Bristol-Myers Squibb's Type II Variation Application for Opdivo (nivolumab) for Treatment of Patients with Resected High-Risk Advanced Melanoma (Press)
  • FDA Grants Cosmo Pharmaceuticals Both QIDP and Fast Track Designations for Aemcolo (Rifamycin SV MMX®) for Travelers' Diarrhea (Press)
  • Appili Receives FDA and Health Canada Clearance to Begin Clinical Trials of its Antibiotic Oral Liquid Reformulation (Press)
  • Rgenix Reports Preliminary Phase 1a/b Clinical Data Demonstrating Immune-stimulatory Activity with RGX-104 in Advanced Cancer Patients (Press)
  • Can-Fite Announces Enrollment of First Patient in its ACRobat Phase III Trial of Piclidenoson in Rheumatoid Arthritis (Press)
  • Efficacy and Safety Results from Second Phase III Trial (RADIANCE™ Part B) of Oral Ozanimod Versus an Active Comparator in Relapsing Multiple Sclerosis (Press)
  • Esanex Presents New Data on SNX-5422 Anti-Tumor Activity Alone and in Combination with Checkpoint Inhibitors at 2017 AACR-NCI-EORTC Meeting (Press)
  • Sunovion Presents Data from Phase 3 Studies of Latuda (lurasidone HCl) in Children and Adolescents with Bipolar Depression (Press)

Medical Devices

  • FDA Finalizes Two Guidances on Sharing Device Data With Patients, Aspirator Device Labeling (Focus)
  • De Novo Classifications: FDA Drafts Guidance on Acceptance Reviews, Finalizes Guidance From 2014 (Focus)
  • Amazon might be more interested in medical devices than pharmaceuticals, one analyst says (CNBC)
  • Clinical Wearables: Navigating the Next Health Technology Boom (MDDI)
  • FDA clears Butterfly Network's iQ 'ultrasound-on-a-chip' (MassDevice)
  • Home HIV tests might increase access to screening (Reuters)
  • Riverfield Surgical Robot Laboratory raises $10m to challenge Intuitive Surgical in Japan (MassDevice)
  • How Medtech Can Brace for Future Natural Disasters (MDDI)
  • Will This Device Change the Orthopedic Rehab Game? (MDDI)
  • Why Baxter is on the Prowl for Acquisitions (MDDI)
  • Scientists See Brain Rewiring Itself to Adjust to Advanced Prostheses (MedGadget)
  • Bracco Group's Acist Medical Systems wins FDA nod for RXi Mini FFR (MassDevice)

US: Assorted & Government

  • House E&C Chair Calls on DoJ for Info, Cooperation on Opioid Inquiries (Letter)
  • Wyden Statement on Opioid Public Health Emergency Declaration (Wyden)
  • NIH announces awards for BRAIN Initiative neuroethics research (NIH)
  • Cruz Introduces Bill to Allow Reciprocal Marketing Authorization (Congress)
  • Large decrease in uninsured new cancer patients linked to Affordable Care Act (Reuters)
  • The Mammography Quality Standards Act – a 25-year Public Health Success Story (FDA Voice)
  • Is FDA's Interim Policy on Section 503B's So-Called "Bulks List 1" Illegal? Did FDA Overstep its Statutory Authority? The U.S. District Court for the District of Columbia May Soon Decide…. (FDA Law Blog)
  • Medtronic v. Lohr Has Two Shadows (Drug & Device Law)
  • PTAB Life Sciences Report (Patent Docs)
  • Obamacare prices hiked up to 38 percent because of Trump threats: Report (CNBC)
  • Despite Good Intentions, IPR Clashes With Hatch-Waxman (Law360-$)
  • Amgen 'Completely Ignoring' Biosimilar Law, Genentech Says (Law360-$)
  • Judge Throws Out Claims of Anticompetitive Behavior Against Suboxone Maker (FDA News-$)
  • Rejecting FTC Drug-Level Standard On Dietary Supplements (Law360-$)
  • Bristol-Myers Dodges Revival Of Abilify FCA Suit At 6th Circ. (Law360-$)

Upcoming Meetings & Events

Europe

  • European Medicines Agency closed 1-3 November 2017 (EMA)
  • London's first medical marijuana conference is a sellout (Financial Times)
  • Cancer competition drives robot surgery, clinic closures in UK (Reuters)
  • HPRA tells drug makers how to get 'GMP inspection-ready' (BioPharmaReporter)
  • Abbott wins CE Mark for next-gen Xience Sierra drug-eluting stent (MassDevice)

Asia

  • Allergan's intravitreal implant wins approval in China (Drug Delivery)

India

  • AIMeD urges govt not to bow down to unethical demands of US medical device cos (PharmaBiz)
  • Why opioid must worry India as much as US (Economic Times)
  • Zydus Cadila gets USFDA nod for skin ointment (Economic Times)

Australia

  • Submissions received: TGA - enhancing sanctions and penalties in the Therapeutic Goods Act 1989 (TGA)

General Health & Other Interesting Articles

  • Black Licorice: Trick or Treat? (FDA)
  • 3 Lessons From An Alarming Case Of Mistaken Cancer Gene Test Results And Surgery (Forbes) (GenomeWeb)

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


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