Regulatory Focus™ > News Articles > 5 > Recon: BioMarin Snags FDA Approval for Palynziq, India Considers Price Controls on More Devices

Recon: BioMarin Snags FDA Approval for Palynziq, India Considers Price Controls on More Devices

Posted 25 May 2018 | By Ana Mulero 

Recon: BioMarin Snags FDA Approval for Palynziq, India Considers Price Controls on More Devices

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In Focus: International Pharmaceuticals & Biotechnology
  • Study says pharma mergers result in fewer new medicines (Axios)
  • In a win for Merck—and, just maybe, for pharma—Solicitor General urges SCOTUS to hear Fosamax case (Fierce)
  • Lilly's cancer business loses its chief just as it's leaning on oncology for growth (Fierce)
  • Those open offices biopharma execs love so much? Most staffers hate them with a passion (Endpoints)
  • Kezar and Xeris file for IPOs, joining May’s march to the public markets (Endpoints)
  • Blink Health alleges MedImpact improperly steers patients toward opioids (MobiHealthNews)
  • A Wish For Nonexistent Cheap Drugs Is Not Standing To Sue (Law360-$)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • NIH summit delivers recommendations to accelerate therapy development for Alzheimer’s disease (NIH)
  • Targovax drug boosts 2-year pancreatic cancer survival (European Biotechnology)
  • Promoting blood vessel growth in bone could treat osteoporosis (Fierce)
  • Gut-liver connection uncovers new avenues for cancer treatment (Fierce)
  • FDA stalls Eisai—and its new partner Merck—in quest to widen cancer med Lenvima's reach (Fierce)
  • Bardoxolone Methyl Improved Kidney Function in Patients With Autosomal Dominant Polycystic Kidney Disease and IgA Nephropathy in the Ongoing Phase 2 Phoenix Study (Press)
  • Bicycle Therapeutics Announces Clinical Milestone & Expands Collaboration with ThromboGenics (Press)
Medical Devices
  • Cook Medical loses Houston-based IVC suit, plans to appeal (MassDevice)
  • Reva Medical’s Fantom bioresorbable scaffold succeeds in two-year trial (DDBN)
  • Biotronik touts two-year study comparing drug-eluting stents (DDBN)
  • Xeris files $75M IPO to fund shelf-stable glucagon rescue injector (Fierce)
  • Foundation Medicine to develop MSI diagnostic for Merck’s Keytruda (Fierce)
  • J&J Claims $70M Award In Surgical Stapler Case Is Unjustified (Law360-$)
  • XableCath Receives Second FDA Clearance for Its Peripheral Arterial Catheters (Press)
  • Mauna Kea Technologies Obtains First Ever FDA Clearance for Applications of Cellvizio Confocal Laser Endomicroscopy in Neurosurgery (Press)
  • BeaconMedaes TotalAlert Scroll Medical Air Systems (ICS-CERT)
US: Assorted & Government
  • Record fentanyl bust in Nebraska finds enough doses to kill an estimated 26 million people (CNN)
  • New Push to Topple Affordable Care Act Looms (WSJ)
  • The challenges of "right to try" (Axios)
  • New bill aims to make sure Medicare customers get drug discounts (Washington Examiner)
  • Pressured by industry, U.S. EPA slows formaldehyde study release: documents (Reuters)
  • With Aspire Deal, Anthem's The Latest Insurer To Seek Medicare's Sickest Patients (Forbes)
  • Express Scripts beats class-action suit over Anthem fallout (Fierce)
  • In a setback to the FTC, a judge dismisses antitrust allegations against Impax Labs (STAT-$)
  • Artificial intelligence is evolving fast. Can the FDA keep up? (STAT-$)
  • Aetna Says Law Firm Responsible For Health Info Breach (Law360-$)
  • AMS’s Proposal for BE (Bioengineered) Labeling; A Number of Questions Remain (FDA Law Blog)
Upcoming Meetings & Events Europe
  • Biocad invests $26 million into infrastructure for creating gene therapies (The Pharma Letter)
  • Transparency data: MHRA Privacy Notice (MHRA)
  • Full Enforcement of Malaysian Medical Device Regulations Set for July 1, 2018 (Emergo Group)
  • Pivotal bioVenture Partners debuts $150M China-focused biotech fund (Fierce)
  • ONO and Bristol-Myers to market Opdivo/Yervoy combo in Japan (The Pharma Letter)
  • Karyopharm and Antengene link up on commercialization in Asia (The Pharma Letter-$) (Press)
  • Jiao Hong, CNDA Commissioner attendees the 2018 China International Meeting on Drug Information and the DIA China 10th Annual Meeting (CFDA)
  • AiMeD terms new MD procurement policy a lost opportunity to promote indigenous manufacturing of medical devices (Pharmabiz)
  • Health ministry to amend Schedule J of D&C Rules to curtail misleading ads (Pharmabiz)
  • New MD public procurement norms come into force; devices need 25-50% local content to qualify for govt purchase (Pharmabiz)
  • Third Indian state checks suspect cases in outbreak of rare brain-damaging virus (Reuters)
  • Odisha health department issues alert (Times of India)
  • The latest outbreak of a deadly virus has scientists racing to create a vaccine (Quartz)
  • What GDPR Means For India: How Europe's Data Protection Law May Indirectly Protect Indian Users (India Times)
  • Australian health head speaks out in support of Taiwan (The Australian)
  • ACV meeting statement, Meeting 6, 7 February 2018 (TGA)
  • Medical devices and IVDs: Suspensions from the ARTG (TGA)
  • Novartis' under-pressure Sandoz unit offloads Quebec plant to fast-growing Avara (Fierce)
  • I-MED Pharma to Bring Clinically Proven E>Eye IRPL Technology to Canada (Press)
  • Anvisa wants to know innovative technologies in Health (Anvisa)
  • Import of health products will have green channel (Anvisa)
  • Exchange of medicines at the pharmacy counter (Anvisa)
General Health & Other Interesting Articles
  • The health care industry is being transformed, one deal at a time (STAT)
  • Study reveals gaps in follow-up care after concussion (NIH)
  • Self-cloning Asian tick causing worry in New Jersey (The Conversation)
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.

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