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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.

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.

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...

EMA Group Questions Notified Bodies Assessing Companion Diagnostics
Published: 5 Dec 2019 | 22:10 UTC

Currently, the EMA doesn’t assess companion diagnostics and genetic testing platforms, because that is handled by notified bodies.

Malaysian Regulator Asks for Comments on Orphaned Devices
Published: 5 Dec 2019 | 22:10 UTC

The agency is proposing that healthcare facilities using the orphaned devices identify and provide notification.

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...

Recon: Sage Depression Drug Fails in Phase III; China’s NMPA Approves Lynparza for Ovarian Cancer
Published: 5 Dec 2019 | 17:55 UTC

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Clarity in Chaos: Best Practice Tips for Engaging Influencers for Pharmaceutical Promotion
Published: 5 Dec 2019 | 17:00 UTC

This article demonstrates how one pharmaceutical company used social media to offer guidance to pharmaceutical companies considering using “media influencers” to promote their products. 
 

FDA Sends Untitled Letter to Company Marketing Stem Cell Treatment for Autism
Published: 5 Dec 2019 | 16:41 UTC

The US Food and Drug Administration (FDA) late last month sent an untitled letter, its third of the year, to California-based Chara Biologics for marketing an unapproved stem cell product as a possible treatment for autism and other conditions with few treatment options.

Human medicines European public assessment report (EPAR): Remsima, infliximab, Arthritis, Psoriatic,Spondylitis, Ankylosing,Colitis, Ulcerative,Psoriasis,Crohn Disease,Arthritis, Rheumatoid, Date of authorisation: 10/09/2013, Revision: 17, Status: Authorised
Published: 5 Dec 2019 | 10:00 UTC

Human medicines European public assessment report (EPAR): Remsima, infliximab, Arthritis, Psoriatic,Spondylitis, Ankylosing,Colitis, Ulcerative,Psoriasis,Crohn Disease,Arthritis, Rheumatoid, Date of authorisation: 10/09/2013, Revision: 17, Status: Authorised

Human medicines European public assessment report (EPAR): Resolor, prucalopride, Constipation, Date of authorisation: 14/10/2009, Revision: 23, Status: Authorised
Published: 5 Dec 2019 | 9:05 UTC

Human medicines European public assessment report (EPAR): Resolor, prucalopride, Constipation, Date of authorisation: 14/10/2009, Revision: 23, Status: Authorised

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.

Mallinckrodt plc Announces Final Results of Exchange Transactions
Published: 5 Dec 2019 | 0:00 UTC

Mallinckrodt plc (NYSE: MNK) today announced (1) the final results of the previously announced offers by its wholly owned subsidiaries, Mallinckrodt International Finance S.A. and Mallinckrodt CB LLC (the "Issuers") to Eligible Holders (as defined below) to exchange (the "Exchange Offers") certain outstanding notes (collectively, the "Existing Notes") issued by the Issuers for new 10.000%

Movement Industries Corp. (OTC: MVNT) Completes Acquisition of SGX Industrial LLC
Published: 5 Dec 2019 | 0:00 UTC

Movement Industries Corp. (OTC PINK: MVNT) announced today that the company has completed the acquisition of SGX Industrial LLC.

Centene and WellCare Receive State Approvals for Pending Merger from Illinois and New Jersey
Published: 5 Dec 2019 | 0:00 UTC

All 27 States Have Provided Approvals of Centene's Control of WellCare Domestic Insurers

Sartorius Acquires a Majority Stake in Cell Culture Media Specialist Biological Industries
Published: 5 Dec 2019 | 0:00 UTC

The transaction is subject to customary closing conditions and expected to be finalized by mid-December.

ViiV Healthcare submits New Drug Application to the FDA for fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV in adults with few treatment options available
Published: 5 Dec 2019 | 0:00 UTC

Fostemsavir is being developed for use in combination with other antiretroviral agents in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection who are unable to form a suppressive regimen due to resistance, intolerance or safety considerations.

Fibriant Expands License Adding Recombinant Human (pro)thrombin to Existing Recombinant Fibrinogen Capability
Published: 5 Dec 2019 | 0:00 UTC

Company on track for clinical studies with RecoSeelTM in mild-to-moderate bleeding in 2021

Human medicines European public assessment report (EPAR): Teysuno, tegafur / gimeracil / oteracil, Stomach Neoplasms, Date of authorisation: 14/03/2011, Revision: 16, Status: Authorised
Published: 4 Dec 2019 | 16:40 UTC

Human medicines European public assessment report (EPAR): Teysuno, tegafur / gimeracil / oteracil, Stomach Neoplasms, Date of authorisation: 14/03/2011, Revision: 16, Status: Authorised

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

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.

Hogan Lovells obtains dismissal of all remaining charges against former New York State Assemblyman
Published: 3 Dec 2019 | 0:00 UTC

2 December 2019 – A New York State Supreme Court judge in Manhattan has dismissed all remaining charges against former New York State Assemblyman Alec Brook-Krasny in a long-running...

GSK Accuses Boehringer Ingelheim of Lying About Its COPD Inhalers
Published: 2 Dec 2019 | 21:51 UTC

GSK demanded that BI stop using a brochure which claimed that a majority of COPD patients would be unable to fully benefit from Ellipta and Diskus.

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

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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 November 2019, PRAC, 29/11/2019
Published: 29 Nov 2019 | 11:00 UTC

At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of...

‘Regulatory science to 2025’: live broadcast of post-consultation workshop on veterinary medicines, , 28/11/2019
Published: 28 Nov 2019 | 13:10 UTC

The European Medicines Agency is hosting a multi-stakeholder workshop on the veterinary medicine aspects of its draft ‘Regulatory Science Strategy to...

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.

A further step towards an EU-wide collective action
Published: 28 Nov 2019 | 0:00 UTC

Today representatives of EU member states agreed on a mutual position regarding the Commission's Proposal for a Directive on representative actions for the protection of the collective...

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.

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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.

Strengthened recommendations for the yellow fever vaccine
Published: 22 Nov 2019 | 11:03 UTC

The Commission on Human Medicines recommends further precautions for people with weakened immunity and in those aged 60 years or older.

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.

Yellow fever vaccine: stronger precautions in people with weakened immunity and in those aged 60 years or older
Published: 21 Nov 2019 | 14:57 UTC

The Commission on Human Medicines has issued a series of recommendations to strengthen measures to minimise risk with the yellow fever vaccine (Stamaril) following very rare fatal reactions.

Carfilzomib (Kyprolis▼): risk of reactivation of hepatitis B virus
Published: 21 Nov 2019 | 14:57 UTC

Establish hepatitis B status before initiating carfilzomib and in patients with unknown hepatitis B virus serology who are already being treated with carfilzomib.

Letters and drug alerts sent to healthcare professionals in October 2019
Published: 21 Nov 2019 | 14:56 UTC

Letters were sent about quadrivalent influenza vaccine, fentanyl ampoules, and Volibris (ambrisentan), and a number of pharmacy-level recalls were issued for ranitidine-containing products.

MHRA drug alert: recalls for 13 over-the-counter Ranitidine medicines
Published: 21 Nov 2019 | 12:29 UTC

A drug alert has been issued to retailers and healthcare professionals as 4 companies are recalling batches of certain over-the-counter Ranitidine medicines used to treat conditions such as stomach ulcers and heartburn.

Digital Transformation: A Guide for Pharma Marketers
Published: 21 Nov 2019 | 0:00 UTC

Artificial intelligence (AI) and machine learning (ML) are not yet perfect sciences, but they are transforming life sciences companies in practical and meaningful ways. This includes improving targeting and relationships with healthcare providers (HCPs) and patients. However, organization

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).

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).

Ranitidine Oral Solution and Tablets recall
Published: 19 Nov 2019 | 12:48 UTC

Ranitidine – MHRA drug alert issued as Creo Pharma Limited and Tillomed Laboratories recall unexpired stock

Dutch authorities hand over final building to EMA in Amsterdam, , 15/11/2019
Published: 15 Nov 2019 | 14:30 UTC

Today, the Dutch authorities have handed over to EMA its newly built tailor-made premises, located in the Zuidas area of Amsterdam. Guido Rasi, EMA’s ...

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

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

A Meaningful Customer-Centric Digital Strategy
Published: 8 Nov 2019 | 0:00 UTC

Data is fast becoming the most valuable commodity known to man. As an infinite resource with evolving applications, the pace at which organizations can acquire, manage the flow of, and leverage data is becoming a crucial factor in the future success of businesses, write Pamela Walk

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).

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.

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.

Opko, BMS aim to develop Alzheimer’s blood test
Published: 23 Oct 2019 | 3:40 UTC

Opko Health Inc. (point-of-care and molecular diagnostics and vaccines) and Bristol-Myers Squibb Co. will nonexclusively collaborate on the further development of Opko’s Alzheimer’s disease blood test.

CellaVision pays SEK268mm for RAL Diagnostics
Published: 12 Oct 2019 | 3:40 UTC

CellaVision AB acquired privately held cellular imaging company RAL Diagnostics for SEK268mm ($29.8mm).

Takeda and Prometheus Biosciences enter IBD partnership
Published: 9 Oct 2019 | 3:40 UTC

Takeda Pharmaceutical Co. Ltd. penned an agreement with Prometheus Biosciences Inc. (formerly Precision IBD) for the discovery and development of up to three new therapies (and related companion diagnostics) for inflammatory bowel disease (IBD).

NeuCyte licenses Trillium's epilepsy candidate
Published: 28 Sep 2019 | 3:40 UTC

NeuCyte Inc. licensed exclusive worldwide development and commercialization rights to Trillium Therapeutics Inc.'s undisclosed refractory epilepsy compound for Dravet syndrome and related disorders.

More batches of common hypertension drug taken off the market
Published: 27 Sep 2019 | 11:00 UTC

Torrent Pharmaceuticals Ltd. is withdrawing more batches of Losartan potassium tablets, USP and Losartan potassium/hydrochlorothiazide tablets, USP.

Value-Based Agency Contracting Clears a Path to Better Outcomes for All
Published: 16 Sep 2019 | 0:00 UTC

Kevin Troyanos Between 2015 and 2017, growth in not-for profit hospitals expenses outpaced growth in their revenues by a full three percentage points, 1 resulting in a collective $6.8 billion of lost earnings. Thanks in no small part to their affiliated hospitals financial struggle

Curetis, OpGen merge
Published: 6 Sep 2019 | 3:40 UTC

Curetis NV and fellow public infectious disease-focused molecular diagnostics firm OpGen Inc. are reverse merging.

Exact Sciences and Genomic Health merge in $2.8bn deal
Published: 31 Jul 2019 | 3:41 UTC

Exact Sciences Corp. and Genomic Health Inc. have agreed to merge in a $2.8bn deal that would create a leading global molecular diagnostics company.

New drug relieves acute migraine in clinical trial
Published: 12 Jul 2019 | 16:00 UTC

The results of a large phase III trial show that the novel drug rimegepant can relieve pain and other symptoms of acute migraine with minimal side effects.

Switching off this enzyme reversed prediabetes in mice
Published: 9 Jul 2019 | 17:00 UTC

A new study shows that deactivating an enzyme that alters ceramides can prevent insulin resistance and fatty liver as well as reverse prediabetes in mice.



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