Regulatory Focus™ > News Articles > 2019 > 7 > Recon: BioNTech Raises $325M for Immunotherapy Pipeline; J&J Partners With Celsius on Single-Cell Se

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

Posted 09 July 2019 | By Michael Mezher 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • 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)
In Focus: International
  • 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)
Pharmaceuticals & Biotechnology
  • 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)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • 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)
Medical Devices
  • 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)
US: Assorted & Government
  • 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)
Upcoming Meetings & Events Europe
  • 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
  • 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)
India
  • 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
  • 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)
Canada
  • Health Canada Consults on Revised Promotion Guidance (Focus)
Other International
  • Election of New Chair and Vice Chairs of The International Coalition of Medicines Regulatory Authorities (ICMRA)
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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