Regulatory Focus™ > News Articles > Regulatory Recon: Pfizer Signs $830M Discovery Pact with Arvinas; Philippines Fines Sanofi, Pulls De

Regulatory Recon: Pfizer Signs $830M Discovery Pact with Arvinas Philippines Fines Sanofi, Pulls Dengvaxia Registration (4 January 2018)

Posted 04 January 2018 | By Michael Mezher 

Regulatory Recon: Pfizer Signs $830M Discovery Pact with Arvinas Philippines Fines Sanofi, Pulls Dengvaxia Registration (4 January 2018)

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

In Focus: US

  • Pfizer lines up an $830M alliance with Arvinas on protein degradation (Endpoints) (Fierce) (Pharmafile) (Press)
  • Drug Policy: The Year In Review, And The Year Ahead (Health Affairs)
  • Momenta, Mylan plan trial of biosimilar to Regeneron eye drug (Reuters)
  • FDA Denies 3rd Allergan Citizen Petition to Block Restasis Generics (Focus)
  • Allergan to cut more than 1,000 jobs as it seeks to lower costs (Financial Times) (CNBC) (Fierce) (8-K Filing)
  • OPDP Letters: FDA Closes Out 2017 With Record Low (Focus)
  • How to survive the biotech blitz that is #JPM18 (STAT)
  • Pence pushing right-to-try bill (Politico)
  • The NIH is in danger of losing its edge in creating biomedical innovations (STAT)
  • FDA Targets Multiple Review Cycles With New Draft Guidance, MAPP (Focus)
  • Pfizer drops iTeos IDO1 cancer drug due to lack of efficacy (Fierce)
  • Novartis' Promacta receives FDA breakthrough designation for new indication (Reuters) (Press)
  • The Opioid Crisis Has Plaintiff Lawyers Smelling Cash (WSJ)
  • We mobilized against flu, cancer and heart attacks. Where's the urgency on opioids? (USA Today)

In Focus: International

  • Chilean lawmakers push for compulsory licenses for hepatitis C drugs (STAT)
  • Philippines fines Sanofi, suspends clearance for Dengvaxia (Reuters)
  • Novartis backs eye drop maker in $20M round, meds to fill gap left by Eylea/Lucentis (Endpoints)
  • Enterome gets €32M, Bristol-Myers Squibb backing, for cancer work (Fierce)
  • BioNTech raises $270M A round to fuel mRNA, CAR-T R&D (Fierce)
  • PIM status for Boehringer's mesothelioma drug (PharmaTimes)
  • Roche aims for MacroGenics bull's-eye with $380M DART deal (Fierce)
  • NHS Overwhelmed in Britain, Leaving Patients to Wait (NYTimes)
  • 2017 A Takeoff Year For China Drug Approvals? (Pink Sheet-$)
  • New Year Debut Of Another Biosimilar Humira In India (SCRIP-$)
  • Australia to permit medicinal cannabis exports in bid to capture lucrative market (Reuters)
  • Suspected diphtheria cases in Yemen near 500: WHO (Reuters)
  • Brazilian Regulators Establish Criteria for Marketing of Unregistered Medical Devices (Emergo)
  • Brazil initiated the implementation of PrEP to prevent new cases of HIV among key higher-risk population groups (PAHO)

Pharmaceuticals & Biotechnology

  • Proclara nabs Merck Alzheimer's R&D executive (Fierce)
  • One-Time Marketing Status Reports Due in February, FDA Says (Focus)
  • JP Morgan preview – Clues on CAR-T uptake and oncology timings (EP Vantage)
  • What price controls? US FDA keeps focus on generic competition (EP Vantage)
  • Alexion concedes to activists, joins forces on director search (Fierce)
  • Hormonal Contraceptive Labeling: FDA Issues Draft Guidance (Focus)
  • Biogen set to raise $300M from New Year's price hikes, just enough to offset MS competition (Fierce)
  • Obstacles to success for biosimilars in the US market (EPR)
  • Roche's Head Of Partnering On Deal Strategies And Aligning Attitudes (SCRIP-$)
  • CDER's 2017 New Drug Class Maintains Steady Innovative Composition With Recent Years (Pink Sheet-$)
  • Somatic Activating KRAS Mutations in Arteriovenous Malformations of the Brain (NEJM)
  • Immune boosting virus could be used to treat brain tumors (Reuters)
  • How alcohol damages stem cell DNA and increases cancer risk (Reuters)
  • Gene Therapy 2.0: New Startups Aim to Fine-Tune Gene Delivery and Control (Xconomy)
  • Atlas builds its dream team and hands over $25M to launch a new approach to gene therapy (Endpoints)
  • On a roll, MacroGenics allies with Roche on a bispecific development campaign (Endpoints)
  • Centrexion's $67M Series D round to fund Phase 3 pain studies (MedCityNews)
  • Cellular barcoding helps scientists understand the behavior of stem cells (NIH)
  • Stem cell transplant for severe scleroderma improves survival, quality of life (NIH)
  • Auromedics Pharma LLC Issues Voluntary Nationwide Recall of Product Ampicillin and Sulbactam for Injection USP 1.5 g/ Vial, Due to Presence of Glass Particles in the Vial (FDA)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Seattle Genetics' Adcetris earns FDA priority review status (PMLive)
  • VenatoRx Pharmaceuticals Receives FDA's QIDP and Fast Track Designations for Development of Its Lead Antibiotic Program (Press)
  • Acacia Pharma Announces FDA Acceptance of NDA Filing For BAREMSIS® for the Management of Post-operative Nausea & Vomiting (Press)
  • Rasna Therapeutics, Inc., Announces Follow Up Phase II Clinical Data Confirming Efficacy of Actinomycin D in Patients with NPM1-Mutated Acute Myeloid Leukemia (Press)
  • Akebia Therapeutics Announces Positive Top-Line Results from Phase 2 Study of Vadadustat in Japanese Patients with Anemia Associated with Dialysis-Dependent Chronic Kidney Disease (Press)
  • Seres Therapeutics Reports SER-287 Phase 1b Microbiome Analyses that Provide Mechanistic Support for Clinical Efficacy in Ulcerative Colitis (Press)
  • Deciphera Pharmaceuticals Initiates Phase 3 Clinical Study with DCC-2618 in Patients with Advanced Gastrointestinal Stromal Tumors ("INVICTUS" study) (Press)
  • Cortexyme Initiates Phase 1 Clinical Development of COR388, a Promising Potential Treatment for Alzheimer's and Other Degenerative Diseases (Press)
  • Exelixis Announces Amendment to Clinical Research Protocol for Phase 1b Trial of Cabozantinib in Combination with Atezolizumab in Patients with Locally Advanced or Metastatic Solid Tumors (Press)
  • ImmunoGen Announces First Patient Dosed in Phase 1 Study of IMGN632 for Hematological Malignancies (Press)

Medical Devices

  • Can Medical Robots Make Mistakes? (Emergo)
  • Medical device companies need to worry more about liability: Here's why (Medical Design & Outsourcing)
  • The Hospital Gown Gets a Modest Makeover (NYTimes)
  • FDA Issues Amended Final Guidance on Medical Device Accessories (National Law Review)
  • Genalyte Takes Aim at Lab Testing Giants with Cloud-Based Service (Xconomy)
  • Zimmer Biomet Announces FDA Clearance of the Sidus® Stem-Free Shoulder System (Press)
  • Hologic wins CE Mark for MyoSure Manual (MassDevice)
  • Gore launches FDA IDE Excluder conformable AAA endoprosthesis trial (MassDevice)
  • InVivo to end Inspire trial despite meeting primary endpoint, plans new study (MassDevice)
  • Glaukos seeks FDA IDE nod for iStent infinite trial (MassDevice)
  • Applied BioCode Submits 510(k) Application to FDA for BioCode MDx-3000 with Gastrointestinal Pathogen Panel (Press)
  • Pixium Vision receives FDA approval to begin human clinical study of its PRIMA sub-retinal implant in the US (Press)

US: Assorted & Government

  • Removing ERISA's Impediment to State Health Reform (NEJM)
  • Amgen Says It Didn't Mislead On Biosimilar Marketing Date (Law360-$) (Patent Docs)
  • Mohawk Tribe Demands Info On 'Impartiality' Of PTAB Judges (Law360-$)
  • Drug Buyers Can't Get Forest Labs Docs Related To Probe (Law360-$)
  • The Pinnacle Hip Implant MDL and the Expert Debacle (Drug & Device Law)
  • Continued Interest in Drug Categorization – OIG Finds Ten Potentially Misclassified Drugs May Have Led to $1.3 Billion in Lost Medicaid Rebates (FDA Law Blog)
  • DOJ Recovered $900 Million From FCA Violators in Pharma Last Year (FDANews-$)
  • Williamson County files lawsuit against opioid manufacturers, distributors (The Tennessean)
  • This Judge Has a Mission: Keep Defendants Alive (NYTimes)

Upcoming Meetings & Events

Asia

  • Illumina and KingMed Diagnostics Partner to Develop Next-Generation Sequencing Technology for Chinese FDA Approval (Press)
  • Looking ahead in China: Celebrating 10 years, promise for the future (USP)

India

  • Glenmark launches biosimilar Adalimumab in India (Economic Times)
  • CCMB sets up India's first gene chip facility (PharmaBiz)
  • DoP rejects Cadila's review petition against ceiling price on paracetamol sustained release 1000mg tablets (PharmaBiz)

Australia

  • Section 19A: Guidance for industry (TGA)
  • Presentations: Codeine up-scheduling workshops, Perth, 30 November 2017 (TGA)

Other International

  • Protecting Medicines Quality in Africa: USP presents at 3rd Biennial Scientific Conference on Medical Products Regulation (USP)

General Health

  • When the Lung Cancer Patient Climbs Mountains (NYTimes)
  • Age may be a factor in facial skin cancer treatment (Reuters)

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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