Regulatory Focus™ > News Articles > 10 > Recon: BMS, Compugen to Test Investigational Antibody and Opdivo in Advanced Solid Tumors

Recon: BMS, Compugen to Test Investigational Antibody and Opdivo in Advanced Solid Tumors

Posted 11 October 2018 | By Michael Mezher 

Recon: BMS, Compugen to Test Investigational Antibody and Opdivo in Advanced Solid Tumors

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • US crackdown on foreign investments could cool Asia’s desire for US biotech (STAT)
  • As China Hunts For New Cures, Investors Flood US Biotech Firms With Cash (Forbes)
  • A growing number of states consider legislation to treat pharma as a utility (STAT)
  • A new era for drug pricing: the ‘accountable choice’ (STAT)
  • Trump signs his first drug pricing bill — but whiffs on the details (STAT)
  • FDA panel backs Celltrion copycat of Roche blood cancer drug (Reuters) (Endpoints) (Press)
  • CRISPR Therapeutics, Vertex set for first sickle cell disease trial after FDA lifts clinical hold — just don’t look for any explanation (Endpoints) (Xconomy)
  • Allogene raises $324m from record-breaking IPO for off-the shelf CAR-Ts (PMLive) (Xconomy)
  • Ionis may have found a home for dry AMD drug with Roche in $760M deal (Fierce) (Endpoints)
  • Price increases on top drugs drove majority of recent growth, analysis finds (BioPharmaDive)
  • Allergan works toward blockbuster goal with new jawline approval for CoolSculpting (Fierce)
  • Chipping Away at Disease—and Drug Testing (WSJ)
  • CVS Health and Aetna $69 Billion Merger Is Approved With Conditions (NYTimes) (Forbes) (CNBC) (DoJ)
  • Sen. Chuck Grassley Asks FTC to Probe Hospital Contracts (WSJ)
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In Focus: International
  • Bristol-Myers to invest in Compugen, collaborate in clinical trials (Reuters) (Endpoints) (Press)
  • WHO sees Congo's Ebola outbreak lasting 3-4 months at least (Reuters)
  • Otsuka and Proteus extend digital drugs tie-up (Financial Times) (Fierce)
  • Rewriting reproduction: With stem cells and CRISPR, scientists breed mice with same-sex parents (STAT)
  • UK pharma leader warns on ‘untenable’ Brexit deal (PMLive)
  • Surging R&D spending in China narrows gap with United States (Science)
  • Top court rules against German certifier in French breast implant case (Reuters)
  • UK and Indian authorities clamp down on international medicines crime (MHRA)
  • Ex-Celgene dealmaker George Golumbeski joins up to guide Carrick on its cancer drug quest — and maybe an IPO as well (Endpoints) (Fierce) (Press)
  • Teva has buyer for plant in Israel that could save 200 jobs: report (Fierce)
  • Brazil's Backlog Is Nearly Clear, But Convergence Still A Work In Progress (Pink Sheet-$)
  • Novartis' Gilenya tops Teva giant Copaxone in head-to-head MS study (Fierce)
  • Can Sanofi's new long-term Lemtrada data amp up sales in a crowded MS field? (Fierce)
  • Health Canada Developing MDL Policies for 3D-Printed Medical Devices (Emergo)
Pharmaceuticals & Biotechnology
  • Biosimilar Suffixes Appear Superfluous In Adverse Event Reporting (Pink Sheet-$)
  • Can Big Pharma's moneymakers stay hot as price hikes slow down? (Fierce)
  • Gene Therapy Company Audentes Raises $151M (BioCentury)
  • Targeting Aging Comes Of Age (LifeSciVC)
  • What’s behind the pharmaceutical sector’s M&A push (McKinsey)
  • FDA’s Insanitary Conditions Revised Draft Guidance: Required Reading for Compounding Facilities (FDA Law Blog)
  • Arie Belldegrun and David Chang score record IPO, now they plan to win the race to a historic FDA OK (Endpoints)
  • Texas-based Children's Health pilots Proteus' ingestible sensor pills for heart transplant patients (mobihealthnews)
  • AcelRx rally quickly fizzles after FDA offers a guarded warning about its latest pain drug pitch (Endpoints)
  • Influenza Virus Vaccine for the 2018-2019 Season (FDA)
  • FDA halts imports from China's Huahai Chuannan plant (Reuters)
  • San Antonio’s BioAffinity Signs Licensing Deal for Cancer Diagnostic (Xconomy)
  • Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination (FDA)
  • Ireland’s largest generics maker invests €86m, targets US market (InPharmaTechnologist)
  • Flu vaccine reduces risk of flu hospitalization among pregnant women (NIH)
  • Ziopharm cuts Precigen ties, narrowing its R&D focus (Fierce)
  • CDMO Almac adding 100 employees to its North Carolina site (Fierce)
  • Balancing innovation and competition in the biologics marketplace (PhRMA)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Transgene to Present Positive Results from Phase 1b Trial of TG1050 in Patients with Chronic Hepatitis B at Upcoming AASLD Liver Meeting 2018 (Press)
  • Synspira Receives FDA Orphan Designation for PAAG15A for the Treatment of Cystic Fibrosis (Press)
Medical Devices
  • TransEnterix Receives FDA 510(k) Clearance for 3mm Diameter Instruments (Press)
  • Medtech reporting would change under new opioid law (MassDevice)
  • FibriCheck's a-fib detection app scores 510(k) clearance, targets 2019 US launch (mobihealthnews)
US: Assorted & Government
  • FACT CHECK: Trump's False Claims On 'Medicare For All' (NPR)
  • Meet the ex-HHS staffer running for Congress (Politico)
  • Investor Says Teva Pharma Lied About Price-Hike Scheme (Law360-$)
  • PTO Final Rule Dropping BRI Patent Claim Standard Offers No Deference To District Courts (Pink Sheet-$)
  • Even in California, Failure To Report Requires Something Reportable (Drug & Device Law)
  • Roche Molecular Systems, Inc. v. Cepheid (Fed. Cir. 2018) (Patent Docs)
Upcoming Meetings & Events Europe
  • CAR-T Funding: It's (Nearly) All About The Price In The UK (Pink Sheet-$)
  • Sequiris invest £40m into expansion of Liverpool plant creating 100 new jobs (Pharmafile)
  • Rivaroxaban (Xarelto▼) after transcatheter aortic valve replacement: increase in all-cause mortality, thromboembolic and bleeding events in a clinical trial (MHRA)
  • Ritonavir-containing products: reports of interaction with levothyroxine leading to reduced thyroxine levels (MHRA)
  • Ponatinib (Iclusig▼): reports of posterior reversible encephalopathy syndrome (MHRA)
  • Transdermal fentanyl patches: life-threatening and fatal opioid toxicity from accidental exposure, particularly in children (MHRA)
  • Letters and drug alerts sent to healthcare professionals in September 2018 (MHRA)
  • Medical Device Alerts issued in September 2018 (MHRA)
Asia
  • Sanofi marches further into China’s rural market (PharmaLetter-$)
India
  • UP to open 6 pharma parks; gets Rs 5,000-6,000 cr commitment (Economic Times)
  • Indian pharma's efforts to market medicines in Japan still an uphill task: Makoto Shigemitsu (PharmaBiz)
  • Aurobindo Pharma gets USFDA nod for infections treatment drug (Economic Times)
Australia
  • Updates on GMP clearance application eforms (TGA)
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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