Ayala Pharmaceuticals has two clinical-stage cancer drugs licensed from Bristol Myers Squibb. Now it has $55 million to take those drugs further than the pharmaceutical giant did. On Thursday evening, Ayala priced its IPO, which consisted of 3.7 million shares sold for $15 each. That price was the midpoint of the targeted $14 to $16 […]

Xconomy is excited to announce we’ve had an overwhelming amount of interest in the inaugural National Xconomy Awards. The hundreds of outstanding nominations highlight the groundbreaking, inspiring companies and individuals we look to honor. Stay tuned for when we reveal the finalists on Monday, June 22. Due to COVID-19 we have postponed the planned June […]

Eil Lilly received accelerated FDA approval Friday for a drug that treats advanced cancers carrying a certain genetic signature. It’s the latest targeted cancer therapy to pass the regulatory bar and the first that addresses tumors characterized by aberrations in one particular gene. The gene in question, RET, produces a protein involved in cell signaling. […]

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.

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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.

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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.

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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.

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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.

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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.

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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

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The companies are committing to find ways to use their businesses to help patients with cancer.

The companyâs SiteVault Free tool, designed to enable collaborating between sites and study monitors, now has a remote monitoring feature.

The group will work to rapidly develop guidance on standardizing COVID-19 research data, with the help of several participating member companies.

The launch of the renamed, newly independent company follows its acquisition by Altaris Capital Partners.

The technology enables sponsors to continue gathering cardiac data for clinical trials without interruption or risk to patient safety.

Today’s guest post comes from Rob Brown, Vice President and General Manager of RxCrossroads by McKesson and Biologics by McKesson.

Rob discusses the importance of access, adherence, and affordability for specialty therapy patients who are uninsured, underinsured, or low-income. He describes three criteria companies should use to evaluate patient assistance program solutions.

Click here to learn more about program pharmacy solutions for biopharma from RxCrossroads by McKesson.

Read on for Rob’s insights.
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Today’s guest post comes from Scott Dulitz, Chief Strategy Officer at TrialCard. Scott discusses how combining payer intelligence with market-leading technology can enhance patient access.

TrialCard recently acquired Policy Reporter, a healthcare software solutions company that provides payer intelligence to the biopharmaceutical, medical device, and diagnostics industries. To learn more, schedule a demo of Policy Reporter or contact Scott (scott.dulitz@trialcard.com).

You can also register for Trialcard’s upcoming webinar: Leveraging Payer Intelligence in Patient Service Programs.

Read on for Scott’s insights.
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Today’s guest post comes from Miranda Gill, Senior Director of Provider Network at CoverMyMeds.

Miranda reviews how the pandemic affects the ability of healthcare workers to complete administrative responsibilities like prior authorization. She then outlines how electronic automation is helping patients get needed medications while face-to-face interactions are restricted.

Learn more about healthcare IT solutions for providers and patients in CoverMyMeds’ 2020 Medication Access Report, or schedule a virtual meeting.
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Rumor has it that Spring has finally reached our worldwide headquarters here in beautiful downtown Philadelphia. (See photo at right.) While we wait to go outside, please enjoy this month’s selection of noteworthy news:

• The outlook for drug prices

• A outstanding (and free!) resource for tracking COVID-19 daily data

• What’s up with community oncology practices?

Plus, I share my favorite chart of 2020 (so far).

P.S. Join the more than 9,200 followers of my curated links to neat stuff at @DrugChannels on Twitter. My recent tweets have highlighted: Prime Therapeutics new gene therapy offering, AmerisourceBergen’s laudable deal with the Justice Department, the Costco/Instacart deal, Rite Aid’s new CEO, clinical trial trends, vaccine pricing, and much more! I have also been tweeting under-the-radar stories about how the coronavirus is affecting drug channels.

Tomorrow (May 1), Drug Channels Institute will host the first of two live video webinars: Industry Update and COVID-19 Impact: Retail & Specialty Pharmacies. We'll host the second video webinar—Industry Update and COVID-19 Impact: PBMs & Payers—on May 8. CLICK HERE TO LEARN MORE AND SIGN UP. Contact Paula Fein (paula@drugchannelsinstitute.com) for our special promo codes for multiple viewing sites. DCI will donate 20% of all profits from these events to The Center for Disaster Philanthropy’s COVID-19 Response Fund.

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Blood tests that find malignancies before they spread could transform our approach to treatment

-- Read more on ScientificAmerican.com

It’s essential if we’re going to protect our planet

-- Read more on ScientificAmerican.com

Events with extreme temperatures and humidity are occurring twice as often now as they were 40 years ago

-- Read more on ScientificAmerican.com

WASHINGTON–(BUSINESS WIRE)–The Association of Clinical Research Organizations (ACRO) is pleased to announce that its Board of Directors has elected John Ratliff, CEO of Covance Drug...

ACRO joins FDA public meeting to discuss trial risks and rationale, benefits and barriers Clinical trials have an enormous number of inter-related,...

On July 17, 2019, under cooperative agreement with the FDA, the Duke-Margolis Center for Health Policy (Duke Margolis) held a public workshop. The event, titled Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations, aimed to identify opportunities to improve Risk Based Monitoring (RBM) implementation and solicit stakeholder input on the challenges, barriers, and enablers that impact the successful adoption of RBM.

On Wednesday, October 23, 2019, ACRO hosted a Congressional Briefing on Capitol Hill. With the help of the Congressional Research & Development...

Washington DC – The Association of Clinical Research Organizations (ACRO) is pleased to announce that its Board of Directors has elected Alistair...

Pharmaceutical company says it can produce tests in the high tens of millions by June

• Coronavirus – latest updates
• See all our coronavirus coverage

The pharmaceutical giant Roche has devised a new coronavirus antibody test, which it is aiming to launch in the UK next month.

Antibody testing, which has already been utilised in Germany, South Korea and Finland, is seen as a way for countries to exit lockdown by showing who has already had Covid-19 and could therefore have a degree of immunity.

Related: Antibody tests aren't perfect, but they may be Britain's way out of the lockdown | Eleanor Riley

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Any vaccine has to work, but it also has to be safe. Making it happen is one of the government’s biggest priorities

• Patrick Vallance is the UK government chief scientific adviser

• Coronavirus – latest updates
• See all our coronavirus coverage

Covid-19 has made fundamental and long-lasting changes to the way we live our lives, not just in the UK, but across the world.

As we continue with social-distancing measures and deal with the most immediate issue of reducing the number of cases to protect the NHS and save lives, and keeping R, which is the average infection rate per person, below one, we also need to progress ways to tackle the disease in the longer term.

The vaccines taskforce will be working in lockstep with the public and private sector

Related: New UK taskforce to help develop and roll out coronavirus vaccine

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The pressing need to find a solution to the pandemic means risks and shortcuts may have to be taken

• Coronavirus – latest updates
• See all our coronavirus coverage

The stakes could hardly be higher; the prize still tantalisingly out of reach. It is no exaggeration to say that the fate of many millions of people rests on the discovery of a vaccine for Covid-19 – the only sure escape route from the pandemic.

Yet the optimism that accompanied the launch of Oxford University’s human trials this week has to be put in context, and the hurdles facing the scientists need to be understood.

Continue reading...

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed that the risks from using Picato are too high to end its suspension.

The South Korean Ministry of Food and Drug Safety have approved a local trial to evaluate nafamostat’s effectiveness in COVID-19 patients.

A Phase 3 study of Sanofi and Regeneron’s Libtayo (cemiplimab) as a monotherapy for advanced or metastatic non-small cell lung cancer (NSCLC) has been stopped early after showing strong overall survival benefit, it has emerged.

The Association of American Physicians and Surgeons (AAPS) wrote a letter to Republican Arizona Governor Doug Ducey urging the wider use of hydroxychloroquine, based on data they have collected.

A US federal judge has ruled that generic versions of the cancer treatment Bendeka infringe on four separate patents, and has delayed them from launching until 2031.

US Secretary of State Mike Pompeo claimed that there is evidence the COVID-19 coronavirus was created in a lab, despite US intelligence officials stating it probably occurred naturally.

President Donald Trump has vowed to cut the US’s reliance on foreign drugs, singling out China and Ireland as countries he wants to stop buying pharmaceuticals from.

Gilead’s antiviral therapy remdesivir has shown tentatively promising efficacy in the race to find an effective treatment for COVID-19, one of the only therapies to do so at this early stage of the pandemic. Now, the FDA has invoked its Emergency Use Authorization powers to approve the drug for the treatment of patients hospitalised with the novel coronavirus.

Sanofi and Regeneron’s have lifted the lid on new topline data on their PD-1 inhibitor Libtayo (cemiplimab) in patients with advanced basal cell carcinoma (BCC), the most common skin cancer in the world, with around two million new cases diagnosed each year in the US alone.

A new online reporting site has been launched by the Medicines and Healthcare products Regulatory Agency’s (MHRA) to track potential side-effects arising from the use of any therapies used to treat COVID-19, in a bid to build a knowledge base around safe treatment of the pandemic disease.

A French patient who suffered from pneumonia in December actually had COVID-19, it has been revealed.

The biotech company Galecto Inc have appointed Jonathan Freve as its Chief Financial Officer, and in his role he will lead financial operations including overseeing investor relations and fundraising efforts.  

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The FDA has awarded marketing authorisation to Novartis for the Oral MET inhibitor Tabrecta for the first-line treatment of metastatic non-small cell lung cancer in patients whose tumors have a mutation that leads to MET exon 14 skipping (METex14), regardless of whether they have previously received any type of treatment.

NICE has revealed that it has recommended the NHS use of Roche’s Kadcyla (trastuzumab emtansine) for HER2+ breast cancer in patients who have residual invasive disease in the breast or lymph nodes after receiving neoadjuvant treatment including a HER2-targeted agent.

Ramps up capacity for testing across the country

Move comes after drug showed preliminary efficacy in clinical trial in late April

Drug could be ready for clinical trials before the end of the year

The U.S. Food and Drug Administration posted a photo:

This product is promoted with unapproved claims to prevent, treat, mitigate, or cure COVID-19. FDA warns consumers to avoid unproven and potentially unsafe products. See the Warning Letter for more information:

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