The agency continues to offer guidance about COVID-19 treatments and testsâand issue warnings to companies that fall out of line.
The pharmaceutical firm has purchased the company, which specializes in advancing treatments and diagnostics for ocular disorders.
CAS, a division of the American Chemical Society, has released a dataset of chemical compounds with known or potential antiviral capabilities.
The companyâs SiteVault Free tool, designed to enable collaborating between sites and study monitors, now has a remote monitoring feature.
The pharmaceutical analysis firm is continuing its contract analytical laboratory services running, with changes designed to keep people and products safe.
The Japanese pharma development firm will harness risk-based quality management solutions to help sponsors improve trial quality and safety.
Over the past week, the agency has issued guidances, taken action to accelerate treatments and put a stop to fraudulent treatments for the pandemic-causing virus.
The solutions enable continuous remote monitoring of body temperature and other vitals, either at home or in care centers, for clinical trials.
Two different groups of researchers have shown that electrical stimulation of the spinal cord, combined with months of intense training, can allow some people who have been paralyzed to regain some walking ability.
The results, if they hold up, are likely to result in many patients getting the medicine, and could upend decades of orthodoxy among cardiologists.
The companies are committing to find ways to use their businesses to help patients with cancer.
uBiome, a San Francisco startup that sells commercial tests that use DNA sequencing to identify what microbes are in a person's stool or, for one test, in the vagina, has raised $83 million from venture capitalists to fund an entrée into drug development.
This morning, Alydia Health, a tiny Menlo Park, Calif., startup co-founded by a 21-year-old woman, announced that it has secured $10 million in funding to test a medical device to prevent mothers from bleeding to death after childbirth.
“John, I’m very aware of your family’s journey, Twelve years ago I was one of the producers considering bidding on your life rights.”
Past experience says that when the FDA has the will to use its regulatory power, it can shake whole industries. Companies like Juul should tread extremely carefully.
Mass shooters appear to injure and kill more people when the use semiautomatic rifles instead of handguns, other types of rifles, or shotguns, according to a new analysis in the Journal of The American Medical Association. But the research has significant limitations.
If we’re going to have a central database of conflict of interest disclosures in medicine – and there is one, created by law – it’s high time that people start using it.
Miami’s Phillip Frost, who built a $2.8 billion fortune in the generic drug business, was allegedly involved in a tawdry stock promotion scheme, the Securities and Exchange Commission says.
Dr Lisa von Moltke has left Aklermes and has joined Seres Therapeutics as its new Chief Medical Officer.
Chief Executive Officer at Seres, Eric Shaff, said Seres will benefit from von Moltke’s “extensive experience directing successful development programs, leading clinical teams, and interacting with regulatory agencies across multiple areas of medicine.”
StrideBio have announced the appointment of Maritza McIntyre Ph.D., as its first Chief Development Officer.
The newly created role will see Dr McIntyre oversea the translational development of the company’s research-stage gene therapy programs. This includes regulatory filings, initiating early clinical studies and starting Investigational New Drug enabling preclinical studies.
BrainStorm Cell Therapeutics, a firm developing cellular therapies to tackle neurodegenerative diseases, has named industry Big Pharma veteran Dr David Setboun as its new Executive Vice President and Chief Operating Officer.
Dr Setboun has served for two decades at some of the biggest names in pharma. His most recent role was Vice President of Corporate Development, Strategy & Business at Life Biosciences, where he helped drive development of a range of vital commercial, operating and funding milestones.
Lumos Pharma, Inc. has promoted Dr John McKew to the position of Chief Operating Officer effective 1 April 2020.
McKew is already Chief Scientific Officer and he will do both roles simultaneously. With his new role, he will lead Lumos’s clinical development plan as the company looks toward adding additional assets to its pipeline.
Ophthalmology specialist Alimera Sciences has announced that Steven T Gill is to return to the company in the newly created role of Vice President, Thought Leader Engagement.
Gill had previously served at Alimera as its Senior Director, Thought Leader Liaison, before leaving the company for Novartis, where he most recently held the position of Associate Director, Thought Leader Liaison at Novartis US.
The Chief Executive Officer of Immuron, Gary S. Jacob, has resigned as CEO and as a member of the Board due to restructering taking place to prepare the company for a post-coronavirus world.
In a statement, the company said it was the first move to help the “preservation of capital to allow the company to weather the current trading conditions pending strengthening of the travel market. This will involve radical cost-cutting and deferring certain research and development activities.”
Genmab has announced the establishment of the new position of Chief Operating Officer at the company, and has furthermore named Anthony Mancini to the post. In this new role, he will oversee the company’s commercial strategies, including corporate development, business development and information technology functions
Data science firm Genomics Plc, which lays claim to “the world’s largest genomic database”, has welcomed Mitchell Harris to the company and its senior leadership team as its Chief Strategy Officer.
Joining from his previous role as Global Head, Emerging Business Lines at Abcam, Harris’ career has given him ample experience in commercial strategy and operations. Prior to his most recent role at Abcam, he acted as the company’s Head of Proteins Portfolio Commercial and Business Development.
Andreas Johannesson has been announced as Alligator Bioscience’s new interim Chief Financial Officer (CFO), replacing ex-CFO Per-Olof Schrewelius who it was previously confirmed will no longer serve the company.
Johannesson’s career has spanned 15 years in the consumer goods sector, with him managing the finances of firms including TeamOlmed, Stenqvist, Fitness23Seven and Haldex.
He spent a further nine years of his career as a strategic consultant with a focus on consumer goods, five of which were spent at global consulting firm McKinsey & Company.
Nordic Nanovector has appointed Dr Lars Nieba as the interim Chief Executive Officer. He is currently the company’s Chief Technology Officer and replaces Eduardo Bravo who as of today has left Nordic to pursue other career opportunities.
Neuronetics, Inc and Chris Thatcher, the President and CEO, have mutually agreed that he will step down from his positions in the company. He will provide transition services and advice to the company until 1 May 2020.
Galecto has announced Bertil Lindmark as their new Chief Medical Officer. He began his posting on 1 February 2020.
Lindmark joins from the eTheRNA immunotherapies, which is a Belgian mRNA immunotherapy company. He has also had an extensive and successful career in the pharmaceutical industry.
Khondrion has revealed that Dr Rob van Maanen has joined the company as its new Chief Medical Officer (CMO).
Dr van Maanen’s career has spanned more than 20 years and seen him take on roles at major industry names such as Roche, Astellas and Eisai. In the role, he will manage the company’s medical operations and clinical strategy.
AI drug discovery firm Exscientia has announced the appointment of Dr David Hallett as its Chief Operating Officer and Head of Drug Discovery.
Bringing 20 years of experience to the role, Dr Hallett’s primary remit will see him take responsibility for the company’s entire drug discovery portfolio, as well as managing pharma collaborations, joint ventures and pipeline projects. He will report to Exscientia Founder and CEO Professor Andrew Hopkins.
Ipsen has named Dr Steven Hildemann as its new Executive Vice President, Chief Medical Officer, Head of Global Medical Affairs and Pharmacovigilance.
In his new role, which begins on 1 March 2020 and will be based in Paris, he will report directly to Ipsen CEO Aymeric Le Chatelier. His remit will include the provision of medical strategy to the company’s scientific, clinical and business teams, while also working in tandem with its R&D operations to design and direct clinical trials efforts to generation of post-launch data.
Saniona has announced that Rami Levin will take over as the Chief Executive Officer of the company as it seeks to transition into a fully-fledge biopharmaceuticals company, with a focus on rare diseases.
Levin was appointed by the Board of Directors and the company’s founders. His appointment takes immediate effect.
Eli Lilly veteran Enrique Conterno has been revealed as the new Chief Executive Officer of FibroGen following the unexpected death of its previous long-term Chief Thomas Neff in August last year.
Neff passing took the company off-guard, bringing a sad and abrupt end to his 26 years of service. In the wake of the loss, FibroGen appointed Board member James Schoeneck to lead the company until a permanent replacement could be found.
The Association of the British Pharmaceutical Industry (ABPI) has appointed Dr Richard Torbett as its new Chief Executive. He will assume the position on 1 January 2020.
The appointment comes after his predecessor, Mike Thompson, stepped down in June. He had served in the role since March 2016. Torbett was unanimously selected by the ABPI board after an external recruitment process with an executive search agency.
Gilead Sciences have announced that Andrew Dickinson has been appointed as Chief Financial Officer (CFO) effective 1 November.
Dickinson currently serves as the company’s Executive Vice President of Corporate Development and Strategy and in his new role will become part of a senior leadership team reporting directly to Chairman and Chief Executive Officer Daniel O’Day.
Gilead Sciences have announced that Merdad Parsey will join the company as Chief Medical Officer, effective November 1st.
Dr Parsey will be responsible for and oversee the company’s global clinical development and medical affairs organisations – reporting directly to Daniel O’Day, Gilead’s Chairman and Chief Executive Officer.
Biogen have announced updates to it senior leadership team with Alfred Sandrock being named Executive Vice President of Research and Development in addition to his responsibilities as Chief Medical Officer. Additionally Alphonse Galdes has been appointed as Executive Vice President of Pharmaceutical Operations and Technology.
In a statement, Michel Vounatsos, Chief Executive Officer at Biogen, said: “Both AI and Alphonse are seasoned and respected leaders at Biogen. Their accomplishment in the scientific community is well-recognised.
MSD have announced that David Peacock will become Managing Director in the UK and Ireland, succeeding former director Louise Houson, with a start date of October 1st 2019.
Peacock brings with him a broad range of experience and perspectives from senior roles within the company in the United States, Singapore, Vietnam and Japan. Most recently, David was Chief of Staff to Kenneth Frazier, Chairman of the board and Chief Executive Officer of MSD.
London consultant and public health professor, Chris Whitty, has begun his role as England’s Chief Medical Officer, taking over from Dame Sally Davies, who has now stepped down from the position.
Whitty has served as the Department of Health and Social Care’s Chief Scientific Adviser since 2016 and was announced as Dame Sally Davies successor earlier in June this year.
Pfizer’s executive chairman Ian Read, is to be succeeded by CEO Albert Bourla with a date to start the post being January 1st 2020.
Mr Bourla, who joined Pfizer’s animal health division in 1993, succeeded Mr. Read from Chief Operating Officer as Chief Executive earlier this year in January, and will now go on to serve as Executive Chairman.
Mr Read has spent nine years in the role and has been at the company for a total of 41 years, first arriving in 1978 and becoming CEO in 2010, joining the board the following year.
Destiny Pharma, a clinical stage biotechnology company focused on the development of novel antimicrobial drugs to address the global crisis caused by antimicrobial resistance (AMR), has announced that after 18 years on the board, Joe Eagle is to step down with immediate effect.
Eagle has been instrumental in the financing and strategic direction of Destiny as a private company and brought his expertise for its lead candidate, XF-73 for the prevention of post-surgical infections. A search for a replacement is underway.
Sir Mark Walport, Chief Executive of UK Research and Innovation (UKRI), the national funding agency responsible for science and research investment in the UK, has announced he is to retire for the role next year.
The decision to leave the organisation in 2020 will mark the end of a three-year tenure at its helm, beginning in 2017 when Walport was appointed to “create a single, ambitious organisation and provide the UK with a world class funding system to keep it at the forefront of global research and innovation”.
Chief Executive of Gulf Pharmaceutical Industries, Jerome Carle, is stepping down from his post at the United Arab Emirates drug manufacturer facing mounting pressure.
Julphar, one of the biggest generic drugs manufacturers in the Middle East and North Africa said Jerome Carle has “tendered his resignation” and the board has accepted it. His last working day will be December 8th.
The General Pharmaceutical Council has appointed Laura Fraser, former clinical fellow for the Scottish Chief Pharmaceutical Officer as the new Director for Scotland.
Fraser has held leadership roles in community pharmacy across Scotland including board member of Community Pharmacy Scotland. She has also worked for the Scottish Government as Clinical Leadership Fellow. Prior to her position as board member she was area and regional manager for nearly nine years.
Immunotherapy-focused pharmaceutical company Midatech Pharma has appointed Stephen Stamp as Chief Financial Officer (CFO) with immediate effect.
He will be replacing Nick Robbins-Cherry, who has stepped down after five years since joining in 2014. Robbins will nevertheless remain at Midatech until October to facilitate Stamp’s handover in an orderly fashion.
Stamp has most recently served as CEO of pharmaceutical firm Ergomed for two years, stepping down in January citing health reasons. Prior to this he was CFO at Ergomed for a year beginning in 2016.
Cerevel Therapeutics, a pharmaceutical company dedicated to treating neurological diseases, has appointed renowned biotechnology leader Tony Coles as Chief Executive Officer (CEO).
AbbVie’s former Vice President of Oncology has moved to Ayala Pharmaceuticals to work as its new Chief Medical Officer (CMO).
Israel-based startup Ayala Pharmaceuticals is a clinical-stage biopharmaceutical company dedicated to developing targeted cancer therapies for people living with genetically defined cancers – it is currently working on the development of its pan-Notch inhibitor AL101, currently in Phase 2 in adenoid cystic carcinoma (ACC).
Troy Robinson has been taken on as the new managing director of Chugai Pharma Europe. Mike Crosher will succeed him in his current role as managing director of Chugai Pharma UK.
Chugai Pharma Europe (CPE) has promoted Troy Robinson and Mike Crosher into the positions of managing director of CPE and managing director of the firm’s UK subsidiary, Chugai Pharma UK (CPU).