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FDA probes diabetes drug metformin for carcinogen NDMA
Published: 6 Dec 2019 | 2:41 UTC

The U.S. Food and Drug Administration is investigating whether the diabetes drug metformin had unsafe levels of a cancer-causing chemical and will recommend recalls as appropriate, the agency said on Thursday.

Inventiva launches with assets from Abbott subsidiary
Published: 6 Dec 2019 | 0:40 UTC

Inventiva Pharma has launched with assets from Laboratoires Fournier (part of Abbott’s Solvay). The assets include laboratories and equipment and a 230k molecule library.

Amgen, Hummingbird Bio team up in potential $1.2bn multi-target collaboration
Published: 6 Dec 2019 | 0:40 UTC

Hummingbird Bioscience and Amgen Inc. are teaming up in a multi-target collaboration.

The J. M. Smucker Company Issues Voluntary Recall of  Specific Lots of Special Kitty® Wet, Canned Cat Food Due to Health Concerns
Published: 5 Dec 2019 | 23:20 UTC

The J. M. Smucker Company today announced a voluntary recall of specific lots of Special Kitty® wet, canned cat food due to health concerns potentially associated with ingredients believed to not meet the Company’s quality and safety standards.

FDA Approves First Gilenya Generics
Published: 5 Dec 2019 | 23:12 UTC

Novartis’ blockbuster multiple sclerosis drug Gilenya (fingolimod) may soon face generic competitors in the U.S., following three FDA approvals.

CDER Recaps New Drug Approvals in 2019, Looks Ahead to 2020
Published: 5 Dec 2019 | 23:11 UTC

The FDA continued to lead the world in new molecular entity approvals in fiscal year 2019, according to a senior official in the Office of New Drugs.

New York doctor convicted of taking kickbacks from opioid maker Insys
Published: 5 Dec 2019 | 23:07 UTC

A New York doctor was convicted on Thursday of accepting thousands of dollars in bribes and kickbacks from Insys Therapeutics Inc in exchange for prescribing his patients an addictive fentanyl spray the drug manufacturer produced.

Biogen builds case for its Alzheimer's drug, skeptics say more data needed
Published: 5 Dec 2019 | 22:45 UTC

Biogen Inc on Thursday laid out more data on its experimental Alzheimer's drug that raised no major safety alarms but also offered little compelling evidence the drug, once declared a failure, actually works.

FDA Approves First Generics of Gilenya
Published: 5 Dec 2019 | 22:12 UTC

December 05, 2019 -- The U.S. Food and Drug Administration has approved three applications for first generics of Gilenya (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients. “Approving safe...

Biogen divulges more data on Alzheimer’s trials
Published: 5 Dec 2019 | 19:14 UTC

Biotech’s shares fluctuate as it tries to win over sceptics of aducanumab

Annual Reported Measles Incidence Dropped From 2000 to 2018
Published: 5 Dec 2019 | 19:00 UTC

THURSDAY, Dec. 5, 2019 -- The annual reported measles incidence decreased from 2000 to 2018, but the number of cases increased from 2016 to 2018, according to research published in the Dec. 6 issue of the U.S. Centers for Disease Control and...

More Than 100 E. Coli Illnesses Now Linked to Romaine Lettuce
Published: 5 Dec 2019 | 19:00 UTC

THURSDAY, Dec. 5, 2019 -- Federal health officials are currently investigating a multistate outbreak of Escherichia coli infection linked to romaine lettuce thought to be grown in Salinas, California. Case numbers have risen from 67 reported a week...

Nassau Candy Distributors Issues Allergy Alert on Undeclared Milk Allergen in Nancy Adams, Dark Chocolate Graham Crackers
Published: 5 Dec 2019 | 16:53 UTC

Nassau Candy Distributors of Hicksville, NY is recalling two lots of 7.5 OZ (212g) Nancy Adams, Dark Chocolate Graham Crackers because they may contain undeclared milk allergens.

Sage crushed by MOUNTAIN as phase 3 depression data fall short
Published: 5 Dec 2019 | 13:15 UTC

Sage Therapeutics’ key phase 3 trial in major depressive disorder has missed its primary endpoint. The failure of SAGE-217 to beat placebo wiped more than 50% off Sage’s share price as investors digested the implications of the data for a critical asset.

Novartis highlights emerging assets and late-stage pipeline at R&D day
Published: 5 Dec 2019 | 12:18 UTC

Also plans to expand established brands into new indications

Aurinia soars as phase 3 lupus study hits primary endpoint
Published: 5 Dec 2019 | 11:46 UTC

A phase 3 trial of Aurinia Pharmaceuticals’ voclosporin in lupus nephritis has hit its primary endpoint, causing the company's share price to double. The data tee Aurinia up to file for FDA approval next year and go on to address a major unmet medical need.

New typhoid vaccine could transform fight against the infection
Published: 5 Dec 2019 | 11:19 UTC

Could help to prevent millions of cases worldwide

Lynparza cleared for first-line ovarian cancer use in China
Published: 5 Dec 2019 | 10:57 UTC

Continues to cement lead in PARP inhibitor category

How worms revealed a key protein in insulin synthesis and diabetes
Published: 5 Dec 2019 | 10:12 UTC

By studying the nematode Caenorhabditis elegans, scientists from Vanderbilt University and the University of Michigan have identified a protein that's key for insulin synthesis, the understanding of which they say could lead to new approaches to prevent and treat Type 2 diabetes and other diseases.

INTCR 2020 Executive Steering Group Chair shares insight into this ever-growing competition
Published: 5 Dec 2019 | 9:27 UTC

Flying the flag for clinical research for over 20 years, this competition continues to grow and develop year after year.

Late-stage Ibsrela success for Ardelyx
Published: 5 Dec 2019 | 9:18 UTC

If approved, the drug will be the only non-binder treatment for the control of serum phosphorus in patients with CKD on dialysis.

EMA to review Amarin’s Vascepa filing
Published: 5 Dec 2019 | 9:14 UTC

The fish oil-derived therapy is already approved in the US for patients with severe hypertriglyceridaemia.

Hanmi gets rights to RAPT's CCR4 antagonist for cancer
Published: 5 Dec 2019 | 5:40 UTC

RAPT Therapeutics Inc. granted Hanmi Pharmaceutical Co. Ltd. exclusive rights to co-develop and sell the CCR4 antagonist FLX475 in South Korea, China, Taiwan, and Hong Kong.

Arecor Announces Positive Headline Results for the First Phase I Clinical Trial of AT247, a Novel Ultra Rapid Acting Formulation of Insulin Favourable pharmacokinetic/pharmacodynamic profile compared to current best in class insulin treatment
Published: 5 Dec 2019 | 0:00 UTC

Arecor Limited announces positive headline results for the Phase I clinical trial of its ultra-rapid acting insulin product candidate, AT247.

BioSpace Global Roundup, Dec. 5
Published: 5 Dec 2019 | 0:00 UTC

Companies from across the globe provide updates on their business and pipelines.

Pivot Pharmaceuticals re-brands as BetterLife Pharma Inc
Published: 5 Dec 2019 | 0:00 UTC

Pivot Pharmaceuticals Inc.announced its corporate name change to BetterLife Pharma Inc.

VivaLnk Earns CE Mark for Multi-Vital Wearable Sensor and SDK
Published: 4 Dec 2019 | 18:59 UTC

The reusable sensor patch weighs 7.5 grams.

Nanomix’s POC Diagnostic for Serious Infections Gains CE Mark
Published: 4 Dec 2019 | 18:56 UTC

The panel is designed to quickly detect life-threatening infections like sepsis and bacteremia.

EmCyte’s Concentrating System Cleared for Gathering Autologous Adipose Tissue
Published: 4 Dec 2019 | 18:55 UTC

The system uses “powerful regenerative bioactive substances to work on transferred tissue without hindering influences,” the company said.

Trump administration willing to drop USMCA pharma provisions
Published: 4 Dec 2019 | 7:09 UTC

Bid to win support from Democrats in deal seen as template for future negotiations

How pot stocks lost their highs
Published: 4 Dec 2019 | 4:00 UTC

Momentum has stalled in key markets such as New York, New Jersey and Connecticut

Dole Fresh Vegetables Announces Precautionary Limited Recall of Colorful Coleslaw
Published: 4 Dec 2019 | 2:05 UTC

Dole Fresh Vegetables, Inc. is voluntarily recalling a limited number of cases of Colorful Coleslaw.

Astellas pays $3bn in cash for Audentes
Published: 4 Dec 2019 | 0:40 UTC

Astellas Pharma Inc. is paying $60 per share (a 112% premium) in cash to acquire seven-year-old gene therapy firm Audentes Therapeutics Inc. The deal has a total equity value of $3bn.

SI-BONE Names Jeryl (“Jeri”) Hilleman to Board of Directors
Published: 4 Dec 2019 | 0:00 UTC

SI-BONE, Inc.,, a Silicon Valley-based medical device company dedicated to solving musculoskeletal disorders of the sacropelvic anatomy, announced that Jeri Hilleman has joined its Board of Directors, effective immediately.

FDA Approves Genentech’s Tecentriq Plus Chemotherapy (Abraxane and Carboplatin) for The Initial Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer
Published: 3 Dec 2019 | 20:12 UTC

South San Francisco, CA -- December 3, 2019 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved Tecentriq (atezolizumab) in combination with chemotherapy...

Soliton Initiates Significant Step Towards Commercialization
Published: 3 Dec 2019 | 0:00 UTC

Engages Tailfin to Support Brand Development Effort for Limited Launch in Tattoo Removal

SI-BONE to Participate at the 31st Annual Piper Jaffray Healthcare Conference on December 5, 2019
Published: 3 Dec 2019 | 0:00 UTC

SI-BONE, Inc. (Nasdaq: SIBN), a medical device company dedicated to solving musculoskeletal disorders of the sacropelvic anatomy, today announced that management will participate in the upcoming 31st Annual Piper Jaffray Healthcare Conference in New York.

Lexicon Loses Appeal of Complete Response Letter for Diabetes Treatment
Published: 2 Dec 2019 | 23:01 UTC

Lexicon Pharmaceuticals has lost its appeal to the FDA of the agency’s complete response letter in March for its investigational add-on type 1 diabetes treatment Zynquista (sotagliflozin).

FDA Approves RediTrex (methotrexate) for Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, and Psoriasis
Published: 2 Dec 2019 | 20:12 UTC

NASHVILLE, Tenn., Dec. 2, 2019 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for RediTrex, its new...

Tories can’t be trusted to look after the NHS | Letters
Published: 1 Dec 2019 | 18:25 UTC

Only Labour’s policies can help solve the healthcare crisis, write 12 nurses. Plus, Dr Robert Oulton says NHS England’s latest reorganisation needs scrutiny, Fiona Henderson worries about price rises in a drug crucial for her husband, and Dr Andrew Hill offers ideas on how to protect the NHS in UK-US trade deals

We are frontline nurses who have faced the reality of government mismanagement over the disastrous years of coalition and Conservatism.

The outlandish and widely ridiculed promise from the Conservatives to recruit 50,000 more nurses (If voters think all politicians lie, then the Tories win, Journal, 30 November) would be unnecessary had they not spent the last nine years driving services and staff to breaking point. Tens of thousands of nursing posts remain vacant, impacting severely on the quality of care our patients deserve. Our colleagues face unprecedented levels of stress and distress in their work, with little support or insight from government.

Continue reading...

There’s a simple way to protect the NHS from US trade negotiators | Emily Jones
Published: 1 Dec 2019 | 14:45 UTC

Pass a law stating the health service is not on the table – this would allow UK negotiators to declare the whole area off limits

No wonder there is alarm when we hear the NHS is on the negotiating table in UK-US talks. In the US, citizens struggle to afford their prescriptions, and medical bills are so high that they are a leading cause of bankruptcy. The US spends more per person on medicines than anywhere else in the world.

The US pharmaceutical industry is large and politically powerful, and the US uses trade deals to pressure other countries to follow its approach to regulation. Throughout this election the Conservative party has made repeated claims that “the NHS is off the negotiating table”, but has not followed up with any efforts to turn this promise into reality.

Related: A US trade deal could cost the NHS tens of millions. My investigation shows how | Antony Barnett

Continue reading...

Asahi Kasei offers to buy Veloxis
Published: 28 Nov 2019 | 5:40 UTC

Asahi Kasei Corp. has offered to pay $0.88 (DKK6.00 each; a 5% premium) for publicly traded Veloxis Pharmaceuticals AS. The deal is valued at $1.31bn.

The Guardian view on Boris Johnson and the NHS: a problem of trust | Editorial
Published: 27 Nov 2019 | 18:56 UTC

The prime minister’s promise to protect the health service in trade talks is made worthless by his record of lies and broken pledges

Whether Conservatives can be trusted with the NHS is an old question at election time. Whether Boris Johnson can be trusted on anything is an issue for the current campaign. The two questions make a dangerous combination for the Tory leader, who is expecting the country to believe that he would protect the health service in a post-Brexit trade deal with Donald Trump.

There is not much reason to believe that he would. On Wednesday Labour sought to probe that concern, revealing documents containing a full account of preliminary discussions between US and UK officials.

Continue reading...

Novartis to acquire The Medicines Co. for $9.7bn
Published: 27 Nov 2019 | 5:40 UTC

Novartis AG agreed to acquire atherosclerotic cardiovascular disease (ASCVD)-focused public US biotech The Medicines Co. (TMC) in an all-cash transaction with a fully diluted equity value of $9.7bn. Approved by both boards, the deal is expected to close in Q1 2020.

Evofem Biosciences Resubmits New Drug Application to U.S. FDA for Amphora® for the Prevention of Pregnancy
Published: 26 Nov 2019 | 3:11 UTC

SAN DIEGO, Nov. 26, 2019 /PRNewswire/ -- Evofem Biosciences, Inc. (NASDAQ: EVFM), a clinical-stage biopharmaceutical company, today announced that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug...

FDA Approves Oxbryta (voxelotor) for the Treatment of Sickle Cell Disease
Published: 25 Nov 2019 | 21:11 UTC

SOUTH SAN FRANCISCO, Calif., Nov. 25, 2019 (GLOBE NEWSWIRE) --  Global Blood Therapeutics, Inc. (GBT) (NASDAQ: GBT) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval...

Zogenix Announces FDA Acceptance for Filing of New Drug Application and Priority Review for Fintepla for the Treatment of Dravet Syndrome
Published: 25 Nov 2019 | 2:11 UTC

EMERYVILLE, Calif., Nov. 25, 2019 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ: ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the...

Dare acquires Microchips to enhance contraceptive offerings
Published: 22 Nov 2019 | 5:40 UTC

Dare Bioscience Inc. acquired private Microchips Biotech Inc. (wireless implantable microchip drug delivery technology) in a stock transaction with the potential for earn-outs.

Sunovion Resubmits New Drug Application for Apomorphine Sublingual Film
Published: 22 Nov 2019 | 2:11 UTC

MARLBOROUGH, Mass.--(BUSINESS WIRE) November 22, 2019 --Sunovion Pharmaceuticals Inc. (Sunovion) today announced the resubmission of the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for apomorphine sublingual film...

ICU Medical buys HD catheter infection-prevention device firm Pursuit Vascular for up to $125mm
Published: 20 Nov 2019 | 5:40 UTC

ICU Medical Inc. agreed to acquire privately held Pursuit Vascular Inc. (device to reduce catheter-related bloodstream infections (CRBSIs) in hemodialysis (HD) patients).

Antares, Idorsia team up to develop drug-device combo product for myocardial infarction
Published: 20 Nov 2019 | 5:40 UTC

Idorsia Pharmaceuticals Ltd. and Antares Pharma Inc. are teaming up to develop a drug-device product that delivers Idorsia’s selatogrel using Antares’ subcutaneous QuickShot auto-injector for adults with suspected acute myocardial infarction (AMI).

Withdrawn application: Opsumit, macitentan, Date of withdrawal: 08/11/2019, Post-authorisation
Published: 15 Nov 2019 | 11:00 UTC

Withdrawn application: Opsumit, macitentan, Date of withdrawal: 08/11/2019, Post-authorisation

Withdrawn application: Luxceptar, viable T-cells, Date of withdrawal: 06/11/2019, Initial authorisation
Published: 15 Nov 2019 | 11:00 UTC

Withdrawn application: Luxceptar, viable T-cells, Date of withdrawal: 06/11/2019, Initial authorisation

Withdrawn application: Linhaliq, ciprofloxacin, Date of withdrawal: 29/10/2019, Initial authorisation
Published: 15 Nov 2019 | 11:00 UTC

Withdrawn application: Linhaliq, ciprofloxacin, Date of withdrawal: 29/10/2019, Initial authorisation

Stryker buys Wright Medical Group; enterprise value of $5.4bn
Published: 7 Nov 2019 | 5:40 UTC

Stryker Corp. is paying $30.75 per share (a 50% premium) or $4.7bn to acquire fellow public orthopedics firm Wright Medical Group NV. The deal has a total enterprise value of about $5.4bn (including convertible notes).

Bryn licenses exclusive global rights to Aptar's bidose nasal delivery device
Published: 26 Oct 2019 | 3:40 UTC

Bryn Pharma LLC licensed exclusive global rights to use Aptar Pharma’s bidose (BDS) nasal device to deliver its epinephrine nasal spray BRYN-NDS1C.

Bausch & Lomb gets US and Canadian rights to Clearside's Xipere
Published: 26 Oct 2019 | 3:40 UTC

Clearside Biomedical Inc. licensed Bausch & Lomb Inc. exclusive rights to develop, manufacture, and commercialize Xipere (triamcinolone acetonide) suprachoroidal injectable suspension for macular edema and uveitis in the US and Canada.

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