Recon: BioNTech Raises $325M for Immunotherapy Pipeline; J&J Partners With Celsius on Single-Cell Sequencing

• Judge Blocks Pharma Prices in TV Ad Rule From Taking Effect (Focus) (NYTimes) (Reuters) (Endpoints)
• Pharma defendants invoke SCOTUS in bid to keep prescription data secret (Reuters)
• GOP senators raise concerns over potential deal to lower drug prices (The Hill)
• Judge dismisses J&J’s request to toss out lawsuit over opioids crisis (The Guardian)
• Trump administration drug officials clash over how to combat fentanyl copycats (Reuters)
• J&J partners with Celsius Therapeutics in large-scale test of single-cell sequencing (STAT)
• BioMarin bustles past enthused rival, planning to launch world’s first hemophilia A gene therapy (Endpoints) (BioPharmaDive)
• Biopharma set for a big buyout year – on dollar terms at least (Evaluate)
• Third Rock cancer startup Revolution Medicines scores $100M in fresh raise (Endpoints) (Xconomy)
• Chinese VC spending on US biotech hit by security reviews (Financial Times) (Endpoints)
• Roche, Merck, Novartis and others hike prices on 83 meds starting in July: analyst (Fierce)
• Novartis launches Adamis allergy shots in US pharmacies amid EpiPen shortage (Reuters)

• Potential IPO candidate BioNTech secures $325 million in financing round (Reuters) (Endpoints) (Financial Times)
• Superbug Threat Sparks U.K. to Test New Antibiotic Pay System (Bloomberg) (PMLive) (ABPI)
• Drug Prices Can Take A Surprising Turn When A Poor Country Gets Richer (NPR)
• UK offers HPV vaccines to boys, aims to stop 100,000 cancer cases (Reuters)
• 'Amazing' gene-silencing drugs reach NHS (BBC)
• WHO keeps key lung cancer drugs off its essential medicines list (Reuters)
• In a first, HKEX receives IPO pitch from local biotech looking to make it big in crowded antibodies field (Endpoints)
• NICE Onpattro approval puts Alnylam back in hATTR running (PharmaTimes)
• Darzalex, Ibrance among latest SMC decisions (PharmaTimes)
• Fosun Pharma picks up GSK plant in China along with rights to make Epivir generic (Fierce)
• Oncology Dominates As China Drug, Biologic Approvals Surge (Pink Sheet-$)
• Swiss court keeps ex-GSK scientist's brother behind bars as US pushes to extradite him on R&D theft charges (Endpoints)

• FDA Leverages Private Sector Technology-Based Tools In Its Embrace Of Real World Evidence (Forbes)
• Offering Emergency Buprenorphine Without a Prescription (JAMA)
• Billionaire Sean Parker is nerding out on cancer research. Science has never seen anyone quite like him (STAT)
• Roche touts torrent of Hemlibra data amid hemophilia gene therapy deal delays (Fierce) (Press)
• New Drug Approvals – A Mid-Year Assessment (Eye on FDA)
• Doctors aren’t much better at picking the best medical treatments than laypersons (LA Times)
• Cigna Invests In GNS Healthcare Precision Medicine Venture (Forbes)
• 12-month supply of birth control pills cuts unintended pregnancies, cost (Reuters)
• ADC Therapeutics has raised $550M-plus in its quest for their first BLA — and here’s why that’s important (Endpoints)
• IGM Biosciences banks a $103M megaround on its quest to pioneer a new kind of cancer-fighting antibody (Endpoints)
• FDA approved a myeloma drug. Some doctors say it was the wrong decision (Medcity)
• Novel Method Identifies Patients at Risk for HIV Who May Benefit From Prevention Strategies (NIH)
• Study finds hospitals continue to mark up medicines up to 500% of their cost (PhRMA)
• Eisai launches first startup incubator under its genomics center for dementia (Fierce)
• Manufacturing Concerns Lead FDA to Pull 31 Apotex ANDAs (Focus)
• FDA to Speed Review of Generic Versions of Opioid Overdose Antidote (Focus)
• Generic Companies Race To Withdraw ANDAs (Pink Sheet-$)
• GSK opens continuous manufacturing plants (PharmaManufacturing)
• Boehringer tests speech as early warning for CNS diseases (PMLive)
• Do doctors prescribe more Lyrica and similar painkillers because they receive pharma money? (STAT)
• Top Woodford lieutenant hits exit in shakeup; Roche posts more impressive data on hemophilia A drug (Endpoints)
• Merck and Biogen both tap Skyhawk’s RNA technology platform (InPharmaTechnologist) (Fierce)
• Celgene turns to Nimbus on ‘highly prized’ I/O target — landing right in Bristol-Myers’ sweet spot (Endpoints) (Fierce)
• Elias Zerhouni: Fear of ‘targeted discrimination’ against Chinese-American scientists threatens an exodus of talent. What do you think? (Endpoints)
• Supplements and Diets for Heart Health Show Limited Proof of Benefit (NYTimes)

• FDA Accepts Merck’s Supplemental Biologics License Applications for KEYTRUDA® (pembrolizumab) Six-Week Dosing Schedule for Melanoma and Multiple Other Indications (Press)
• NeuroRx Initiates Pivotal Study for NRX-101, a Breakthrough Designation Therapy Targeting Suicidal Bipolar Depression (Press)
• Aerie Pharmaceuticals Completes Enrollment of the Netarsudil Ophthalmic Solution Phase 2 Clinical Trial in Japan Months Ahead of Schedule (Press)

• icotec AG Granted FDA Clearance To Market VADER®one Pedicle Screw System (Press)
• FBI Approves Thermo Fisher NGS Forensic Profiling Solution (GenomeWeb)
• FDA approves ConTIPI Medical’s ProVate pelvic organ prolapse treatment (MassDevice)

• Obamacare in Jeopardy as Appeals Court Hears Case Backed by Trump (NYTimes)
• Sanofi, Eisai join Lilly's SCOTUS bid to save Cialis from 'overly broad' patent claims (Fierce)
• Safeguards Must Be Strengthened To Protect Medicare Hospice Beneficiaries From Harm (HHS OIG)
• FDA Should Act Fast Amid Youth Vaping ‘Epidemic’ (Bloomberg)
• How Trump wants to shake up kidney care market (Politico)
• CREATES Act Approaches Finish Line But Legislation May Fail To Launch (Pink Sheet-$)
• New CRISPR Interference: The Details (Patent Docs)
• Ex-Insys Bosses Still Aiding 8 Kickback Probes, Feds Say (Law360-$)
• Guest Post – Stop the Presses – Supreme Court Decides a Dormant Commerce Clause Case (Drug & Device Law)

• FDA Advisory Committee Calendar
• Incorporating Alternative Approaches in Clinical Investigations for New Animal Drugs; Public Meeting – 16 July 2019

• Involved & informed: good community medicines support (NICE)
• Recommendations for Timely Access to Advanced Therapy Medicinal Products (ATMPs) in Europe (ARM)
• UL UK to Sunset Operations Under EU’s Medical Device Directive (Focus)
• Spanish Regulator Revokes GMP Certificate of Generic Drugmaker (Focus)
• Swissmedic Journal – June 2019 (Swissmedic)
• EU 'Aide-Memoire' Outlines Systems That Should Be In Place For Compliance With FMD (Pink Sheet-$)
• Implementing the Falsified Medicines Directive: Safety Features (MHRA)

• Asia Regulatory Roundup: China Reports Sharp Increase in Applications to Drug Review Center (Focus)
• China NMPA’s new eRPS medical device registration system: A closer look (Emergo)
• Philippines warning over falsified GSK rabies vaccine (Securing Industry)
• Japan approves iSchemaView’s Rapid stroke imaging device (MassDevice)

• Dr Reddys launches anti-phlegm OTC drug in US market (Economic Times)
• Glenmark gets final nod from USFDA for angina treatment drug (Economic Times)

• Australia regulators publish guidance on recognized QMS standards (MassDevice)
• TGA strengthens regulation of stem cell treatments (TGA)
• Permitted indications for listed medicines guidance (TGA)
• Submissions received and summary: Proposal for the regulation of IVD companion diagnostics (TGA)

• Health Canada Consults on Revised Promotion Guidance (Focus)

• Election of New Chair and Vice Chairs of The International Coalition of Medicines Regulatory Authorities (ICMRA)