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Report: Pharma kicks off year with drug price hikes

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Reuters reports that a number of big-name drugmakers, including Pfizer, Sanofi and Takeda plan to raise drug prices to start the year.

According to the report, the price hikes apply to more than 500 drugs. Excluding different doses and formulations, the reach extends to more than 140 brands of drugs. Reuters said healthcare research firm 3 Axis Advisors analyzed data that uncovered these increases.

This move comes just weeks after the Biden Administration signaled its intent to target the pricing of dozens of prescription drugs. The Administration announced a strategy under the Inflation Reduction Act to focus on 48 Medicare Part B drugs that have raise…

GlaxoSmithKline officially rebrands as GSK

GlaxoSmithKline (NYSE:GSK) has long gone by its acronym GSK. Now, the abbreviation is the company’s official name.

GlaxoSmithKline had announced its plan to change the name in an earnings announcement in April 27.

The London Stock Exchange and the New York Stock Exchange will update the company’s name in “due course,” as the company explained in a news release.

GlaxoSmithKline got its name from the 2000 merger of Glaxo Wellcome and SmithKline Beecham. In that deal, Glaxo Wellcome paid $75.7 billion to acquire its then competitor, creating what WSJ called in 2000 the “world’s No. 1 drugmaker.”

Now, GSK is in the process of creating a consumer health spinoff known as ‘Haleon.’

GSK’s consumer segment makes an array of products, including Centrum vitamins, Sensodyne toothpaste, and the pain-reliever brands Excedrin, Advil and Panadol.

The company’s decision to simplify its…

GSK to name Vishal Sikka to its board

GlaxoSmithKline plc (LSE/NYSE:GSK) has announced that the CEO of Vianai Systems, Vishal Sikka, will join its board as a non-executive director.

Vianai Systems is a Bay Area startup focused on ‘human-centered AI.’

Sikka will join after GSK spins off its consumer segment, which it will term ‘Haleon.’

At GSK, Sikka will provide perspective on AI, which GSK says is ‘central’ to its R&D.

Sikka has also worked as the CEO of Infosys, a management consulting firm and as a member of the board of German software giant SAP. Sikka also was named SAP’s first CTO in 2007. He decided to step down in 2014.

VishalSikka pictured in 2010. [Image courtesy of Wikimedia]

Sikka also serves on the board of directors of Oracle and BMW.

“I am delighted to welcome Vishal to GSK. He is an experienced board director and an outstanding technologist who has been at the forefront of advance…

FDA further limits use of GSK’s and Vir’s SARS-CoV-2 antibody sotrovimab

As the omicron BA.2 subvariant has spread, FDA has announced that it will further constrain the use of the investigational monoclonal antibody sotrovimab. The agency announced that it would limit the use of the antibody in some U.S. regions last week.

GlaxoSmithKline plc (LSE/NYSE:GSK) and Vir Biotechnology (Nasdaq:VIR) were initially confident that the antibody could hold up to the first omicron subvariant, but the companies have concluded that it is probably ineffective against the BA.2 subvariant.

The FDA has announced that sotrovimab is not currently authorized in areas where the BA.2 subvariant makes up the majority of COVID-19 infections. These areas include the Northeast, much of the Western part of the country and a portion of the Midwest.

The FDA has also withdrawn authorization for sotrovimab in Alaska and major U.S. territories, including Puerto Rico.

Last year, FDA similarly limited the use of Lilly’s bamlanivimab (LY-CoV555)…

Roche to donate essential medicines to Ukraine

Roche (SIX:RO, ROG; OTCQX:RHHBY) announced that it would ship 150,000 packages of the antibiotic Rocephin to Ukraine, among other medical supplies, including diagnostics.

Rocephin is a broad-spectrum cephalosporin antibiotic.

The World Health Organization cites it as an essential medicine.

Basel, Switzerland–headquartered Roche noted in a statement that it is working with various international and local partners to ensure delivery to the war-torn country. It also vowed to continue delivering medical supplies to Russia and Belarus “within the scope of the available possibilities.”

The Ukrainian government estimated that approximately 2,000 civilians had died in the attacks to date, although Ukraine’s emergency services agency underscored that the number was “approximate.”

Roche noted that it had enrolled Ukrainian patients in ongoing clinical trials and said it would work to ensure continued access to treatment to those individuals.

O…

J&J and Roche named to Clarivate’s Top 100 Global Innovators list

Photo by Chokniti Khongchum from Pexels

Few healthcare companies were included in the annual ranking of innovative companies from the analytics firm Clarivate plc (NYSE:CLVT).

Two companies in pharma and another in medtech, however, made the cut.

Johnson & Johnson was featured for the second consecutive year as a top 100 Global innovator.

Roche was included for the 11th consecutive year in the report.

In medtech, Philips was included for the second consecutive year.

Clarivate notes the fragmented nature of pharmaceutical research contributes to the limited number of companies in the ranking. Given the elevated role of academia and contract firms in drug discovery and development, it is more challenging for any single entity to stand out in the industry.

Additionally, Clarivate concluded that the ability of the pharmaceutical sector to innovate has fallen since last year…

GSK names consumer health spinoff ‘Haleon’

GlaxoSmithKline plc (GSK) is moving forward with a planned demerger of its consumer healthcare segment, which it will call Haleon.

The company notes that the name is a portmanteau of the old English word ‘hale’ and the name ‘Leon.’ The former means ‘healthy’ while the latter is a reference to strength.

In the past eight years, GSK integrated its consumer health unit with similar divisions from Novartis and Pfizer. The unit generates approximately £10 billion in annual revenue.

Earlier this year, Unilever (LON:ULVR) offered to buy the unit for £50 billion (about $68 billion) but was rebuffed. Haleon will have a portfolio of brands including Centrum vitamins, Sensodyne toothpaste, the arthritis gel Voltaren and the acetaminophen brand Panadol.

“Haleon has enormous potential to improve health and wellbeing across the world with strong prospects for growth, and through listing will unlock significant value for GSK shareholders,” said Emma Walmsley,…

GSK rebuffs Unilever’s offers to buy its consumer healthcare arm

GlaxoSmithKline (GSK; NYSE:GSK) plc announced that it had received three unsolicited proposals from Unilever plc (LON:ULVR) to buy its GSK Consumer Healthcare unit for £50 billion (about $68 billion).

GSK rejected the offers, explaining in a statement that the proposals “fundamentally undervalued” the business unit.

Last year, the division generated £9.6 billion in revenue.

Despite being thrice rejected, Unilever said it still was interested in acquiring the GSK unit, which manufactures products ranging from pain relievers like Advil to toothpaste.

Investors reacted by sending ULVR shares down 3.86% to £3,520.50.

Conversely, GSK shares were up 2.97% to $46.82.

The rating agency Fitch concluded that it could downgrade Unilever’s credit rating from A with a “stable” outlook to BBB if it executed such a large deal.

The analyst Bruno Monteyne at Bernstein described the proposed merger as “a very bad deal.”

GSK Consumer Heal…

GSK and Vir file for EUA for intramuscular administration of sotrovimab to treat COVID-19

GlaxoSmithKline (LSE/NYSE GSK) and Vir Biotechnology (NSDQ:VIR) are seeking to expand the use of the investigational monoclonal antibody sotrovimab.

Intravenous sotrovimab is currently authorized to treat mild-to-moderate COVID-19 in patients at least 12 years of age, weighing at least 40 kg (88 pounds). The authorization is constrained to patients who face a high risk of developing severe COVID-19.

Sotrovimab won emergency use authorization (EUA) in the U.S. in May 2021. In addition, it won EU marketing authorization as an early COVID-19 therapy in December 2021.

The companies note that data from the Phase 3 COMET-TAIL trial found that 500-mg intramuscular injection of the monoclonal antibody was non-inferior to intravenous injection.

Interim data from that trial was published in The New England Journal of Medicine last year. Final data were published as a pre-print on medRxiv. GSK and Vir Biotechnology anticipate that the full data will be publi…

Sotrovimab wins EU marketing Authorization as an early COVID-19 therapy

GlaxoSmithKline (LSE/NYSE:GSK) and its partner Vir Biotechnology (NSDQ:VIR) have received marketing authorization from the European Commission for the dual-action monoclonal antibody Xevudy (sotrovimab).

The marketing authorization covers individuals 12 and older who weigh at least 40 kg who do not need supplemental oxygen. It also requires that such individuals have a heightened risk of developing severe COVID-19.

This summer, GSK and VIR had reached a joint procurement agreement with the EC involving 220,000 doses of the drug.

“With today’s marketing authorization we are now able to expand access, and we are discussing with governments how we can bring sotrovimab to more patients,” said Dr. Hal Barron, chief scientific officer and president R&D of GSK, in a statement.

The two companies also have revealed that preclinical data suggest that sotrovimab retains activity against the Omicron variant, which threatens to become the dominant form of …

GSK and Vir upbeat about efficacy of sotrovimab against Omicron

GlaxoSmithKline (LON:GSK) and its partner Vir Biotechnology (NSDQ:VIR) have announced that their COVID-19 drug sotrovimab continues to offer protection against the mutations in the spike protein of the Omicron SARS-CoV-2 variant.

In March, the two companies received emergency use authorization (EUA) for the drug. The EUA specifically covers the treatment of mild-to-moderate COVID-19 in high-risk adults and children.

Drawing on preclinical research, the two companies suggest that at least one dose of sotrovimab would protect against Omicron, which WHO has categorized as a variant of concern. The preclinical research involved pseudo-virus testing, including 37 mutations in the Omicron variant spike protein.

Formerly known as VIR-7831, sotrovimab is a monoclonal antibody.

The antibody is the first with “preclinical data demonstrating activity against all tested SARS-CoV-2 variants of concern and interest to date, including Omicron, as well as the sti…

GSK touts DREAMM clinical trial headway in multiple myeloma

GlaxoSmithKline (NYSE:GSK) will present 11 abstracts on Blenrep (belantamab mafodotin blmf) at the American Society of Hematology (ASH) Annual Meeting and Exposition on December 11–14. Presentations will include new data from the DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) clinical trial program and two collaborative studies focused on Blenrep.

The drug won FDA approval on August 5, 2020, for adults with relapsed or refractory multiple myeloma who have received at least four prior therapies.

Featured presentations at ASH includes poster #2738, which will describe outcomes of regimen of belantamab mafodotin with the chemotherapies bortezomib and lenalidomide plus the steroid dexamethasone in transplant-ineligible patients with recently diagnosed multiple myeloma.

Another presentation will detail results from the BelaRd trial (poster #2736) from Hellenic Society of Hematology in collaboration with GSK exploring a similar cocktail mentione…