GlaxoSmithKline plc Archives - Medical Design Sourcing

GSK to purchase biopharma Sierra Oncology for $1.9 billion

GlaxoSmithKline plc (LSE/NYSE:GSK) has reached a deal to acquire Sierra Oncology (Nasdaq:SRRA) to bolster its oncology pipeline.

Under the terms of the proposed deal, GSK would pay $44 per share for a total value of approximately $1.9 billion.

GSK shares were mostly flat in mid-day trading, dipping 0.032% to $46.52. SRRA shares surged 38.31% to $54.66.

Sierra Oncology’s differentiated momelotinib, which inhibits JAK1 and JAK2, offers potential for patients with myelofibrosis, a rare bone marrow cancer. Myelofibrosis can lead to scarring in the bone marrow, thus causing severe anemia.

GSK expects to benefit from sales of momelotinib starting in 2023, with growth ramping up after that.

There is a significant unmet need for patients with myelofibrosis. Roughly 40% of patients diagnosed with myelofibrosis are already anemic, with the majority developing anemia eventually.

Momelotinib has been the subject of 22 clinical trials to date. Read more

Chinese regulators approve GSK’s Benlysta for lupus nephritis

GlaxoSmithKline plc (LSE/NYSE:GSK) has announced that China’s National Medical Products Administration (NMPA) has approved Benlysta (belimumab) for the treatment of adult patients with active lupus nephritis (LN), a type of kidney disease affecting more than half of those with systemic lupus erythematosus (SLE).

Benlysta is the only biologic approved to treat SLE and lupus nephritis in China.

The recent indication is constrained to patients receiving standard of care for LN.

The indication for SLE, the most common form of lupus, covers adults and children at least five years old.

FDA approved Benlysta as a lupus treatment in 2011. Approval extended to children at least five years old in 2019. In December 2020, FDA approved an indication of the drug for adults with lupus nephritis.

NMPA approved the new indication after reviewing data from the BLISS-LN (Efficacy and Safety of Belimumab in Adult Patients with Active Lupus Nephritis) Phase stu…

ACIP votes unanimously backs GSK’s shingles vaccine Shingrix for immunocompromised adults 19 and older

CDC’s Advisory Committee on Immunization Practices (ACIP) unanimously recommended two doses of GlaxoSmithKline’s (NYSE:GSK) Shingrix (a recombinant adjuvanted zoster vaccine) for adults 19 and older with immunodeficiency or immunosuppression as a result of disease or therapy.

CDC considers Shingrix to be an adult vaccine, and its recommendation is for the adult immunization schedule, which begins at the age of 19.

In addition, ACIP was unanimous in backing Merck’s (NYSE:MRK) and Pfizer’s (NYSE:PFE) pneumococcal vaccines in elderly and immunocompromised adults.

ACIP will share the recommendations with the director of the CDC and the US Department of Health and Human Services for review and approval.

Shingrix first won FDA approval in 2017 to prevent shingles in adults aged 50 and older. In July of this year, the agency extended approval to include adults aged 18 and older with an elevated risk of developing shingles as a result of immunodeficiency …

Pharma 50: Here’s how the world’s largest pharma companies are doing

The global pharmaceutical industry held up well during the pandemic, with 10 of the largest businesses only seeing a roughly –3% drop in revenue in 2020. Eight of the 10 even came out ahead.

That’s one of the big takeaways from our sister publication Drug Discovery & Development’s inaugural Pharma 50, a compilation of data on the largest pharma companies in the world. (Browse data on all 50 companies here.)

Overall, the 50 largest pharma companies brought in $851 billion in sales in 2020. Pharma companies last year overcame clinical trial disruption and staffing hurdles to drive unprecedented R&D advances to introduce novel vaccines and therapies to battle the pandemic. The resulting shift in public perception could benefit the industry for years to come.

Get the full story on our sister site Drug Discovery & Development.

Former head of Operation Warp Speed leaves two more drug companies

Following allegations of sexual harassment, former head of Operation Warp Speed Moncef Slaoui has left roles at two more companies.

Yesterday, Slaoui was terminated as the chair of the Galvani board of directors, GlaxoSmithKline’s board of directors announced. The same day, Vaxcyte confirmed in an SEC filing that it had axed Slaoui as its chairman of the board. Today, Centessa Pharmaceuticals announced that he stepped down as the company’s chief scientific officer.

Get the full story at our sister site, Drug Discovery & Development.

Former head of Operation Warp Speed loses board seat over sexual harassment claims

GlaxoSmithKline’s board of directors announced today that it terminated Moncef Slaoui as the chair of the Galvani board of directors.

Slaoui, who served as the head of Operation Warp Speed — the Trump administration’s program to accelerate COVID-19 vaccine development — was terminated effective immediately, according to a news release from GSK, the majority shareholder of Galvani Bioelectronics.

Get the full story at our sister site, Drug Discovery & Development.

Biden announces $4B to support global vaccinations worldwide

[Photo by Daniel Schludi on Unsplash]President Joe Biden announced that the U.S. is set to provide $4 billion to the COVAX Facility to support access to safe and effective COVID-19 vaccines.

Money appropriated by a December 2020 Congressional vote will comprise an initial $2 billion contribution to Gavi, the Vaccine Alliance for the COVAX advance market commitment (AMC) covering 92 low- and middle-income economies, according to a White House Statement.

Get the full story at our sister site, Pharmaceutical Processing World.

Sanofi to provide COVID-19 vaccine manufacturing for rival Pfizer

Sanofi (NYSE:SNY) announced today that it entered into an agreement to support the manufacturing and supply of the Pfizer/BioNTech COVID-19 vaccine.

Pfizer and BioNTech’s vaccine is one of two to receive FDA emergency use authorization in the U.S. and it also has clearance in Europe, having received both nods in December 2020.

The deal between Sanofi provides BioNTech access to its infrastructure and expertise to produce over 125 million doses of the COVID-19 vaccine in Europe. Initial supplies will originate from Sanofi’s production facilities in Frankfurt starting in the summer of 2021, according to a news release.

Get the full story at our sister site, Pharmaceutical Processing World.

Drug companies agree not to release COVID-19 vaccine until it’s ready

[Photo by Fusion Medical Animation on Unsplash]

Executives from nine different drug companies today announced a pledge to ensure safety with a potential COVID-19 vaccine.

The CEOs of AstraZeneca (NYSE:AZN), BioNTech (NSDQ:BNTX), GlaxoSmithKline (NYSE:GSK), Johnson & Johnson (NYSE:JNJ), Merck (NYSE:MRK), Moderna (NSDQ:MRNA), Novavax (NSDQ:NVAX), Pfizer (NYSE:PFE) and Sanofi (NYSE:SNY), all of whom are developing vaccine candidates, all signed the pledge, which vows to “uphold the integrity of the scientific process” as they pursue regulatory approvals of the first vaccines for the novel coronavirus.

“FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US,” the pledge states. “FDA’s guidance and criteria are based on the scientific and medical principles necessary to clearly dem…

DTW Podcast: Truist’s Kaila Krum says Medtronic prepping for growth

In an interview with DeviceTalks Weekly Podcast, Truist Securities managing director Kaila Krum says Medtronic executives are retooling the company to keep pace with smaller, more focused competitors.

Breaking down the company’s Q1 call, Krum says Medtronic is seen as a company that’s too big to grow market share quickly. On the call, new CEO Geoff Martha emphasized gaining market share at one point telling investors the company would “go big or go home.”

Krum says Medtronic will pour resources into several critical areas to drive growth including soft tissue robotics, diabetes, and renal denervation.

“At a time when a lot of companies right now are forced to pull back on spending, Medtronic has been in a position where it can flex its balance sheet,” Krum said. “So they’ve been talking about investing in the pipeline, investing in structural, operational and cultural changes. I think all of that combined should support their growth goals over the …

MedTech 100 roundup: Industry hits another mid-pandemic high

Despite a minor regression week-over-week, the medtech industry’s stocks hit another milestone as the COVID-19 rebound remains in progress.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 89.01 points at the end of last week (July 31). Overall, medtech stocks saw a -0.3% increase from the 89.29-point total at the same time a week prior (July 24).

On July 30, the index reached 90.37 points, marking its highest point since that pre-pandemic high, with the previous mid-pandemic high (90.11) coming last week.

The most recent high mark represents just a -2.1% dip from the Feb. 19 high point of 92.32, marking the smallest margin of decline over the past five months.

Meanwhile, the S&P 500 Index saw a 1.7% increase from July 24 to July 31, and the Dow Jones Index posted a -0.2% drop over the same period of time.

Medtech’s lowest point during the COVID-19 pandemic remains at …

GSK, Sanofi land $2.1B from feds to develop COVID-19 vaccine

The Trump administration has awarded Sanofi (NYSE:SNY) and GlaxoSmithKline (NYSE:GSK) a contract for up to $1.2 billion to develop, manufacture and deliver a vaccine for COVID-19, the companies announced today.

The vaccine candidate is based on the recombinant protein-based technology used by Sanofi to produce an influenza vaccine, and GSK’s established pandemic adjuvant (immunity-boosting) technology. Manufacturing will take place in the U.S.

Get the full story on our sister site, Pharmaceutical Processing World.