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

• BioMarin scores long-sought FDA nod for Palynziq, but its $192K launch could be tough (Fierce) (BioPharma Dive) (PMLiVE) (Endpoints) (Reuters) (PharmaTimes)
• Imagen Tech wins de novo clearance for OsteoDetect wrist fracture software (MassDevice) (MIT Technology Review) (MD Magazine) (FDA)
• Prothena axes half its staff after phase 3 catastrophe (pharmaphorum) (Fierce) (Scrip-$)
• AstraZeneca caps its big win in lung cancer with positive survival data for Imfinzi — and what a relief it is (Endpoints) (Fierce) (BioPharma Dive) (Reuters) (pharmaphorum)
• Celgene’s R&D report card ‘somewhat disappointing,' say analysts (Fierce) (Endpoints)
• Genmab/Novatis’ Arzerra fails to hit NHL targets (PharmaTimes) (BioPharma Dive)
• Zydus Cadila gets USFDA nod for prostate drug (Business Line) (Economic Times)
• Swallow this: A sensor could monitor gut health via engineered bacteria — and beam results to a smartphone (STAT) (USA Today) (AP News)

• Govt plans regulations for critical medical devices like pacemaker, X-ray machines (Economic Times) (Business Today) (CDSCO)
• Nordic Pharma and Clinigen sign global Trasylol supply deal (Fierce) (BioSpectrum)
• Flu vaccine to be reserved for most vulnerable as supplies dry up (The Age) (The Sydney Morning Herald) (SBS News) (The Courier)
• Polio eradication initiative meets resistance to appeals to destroy samples (STAT)
• Global health shifts to local experts with global partners (Science Magazine)
• EU's GDPR privacy law is here: Are you certain your U.S. organization is compliant? (Healthcare IT News)
• “There is no Big Brother”: Tim Kelsey sells My Health Record as an innovation in consumer empowerment (Healthcare IT News)

• 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-$)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar

• 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)

• 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)