Search Results for “GSK ” – Page 14 – media

Chasing AstraZeneca and Pfizer, Johnson & Johnson snags FDA nod for prostate cancer combo Akeega

Following FDA approvals for fellow PAPR inhibitors made by AstraZeneca/Merck and Pfizer, Johnson & Johnson has got its own combo approval in prostate cancer. The tablet treatment, known commercially as Akeega, combines J&J’s androgen-directed Zytiga (abiraterone acetate) and the PARP inhibitor niraparib, which is sold by GSK as Zejula in other indications. The FDA has signed off on its use along with the corticosteroid prednisone, but only in a subset of mCRPC patients—those with BRCA mutations. Akeega will compete with AstraZeneca and Merck’s Lynparza as well as Pfizer’s Talzenna in the indication. Eleven weeks ago, the FDA gave Lynparza the same narrow label for those with the BRCA-positive tumors. Talzenna’s approval covers a broader population, including other mutations in the homologous recombination deficiency family. Under a 2016 deal with Zejula’s developer Tesaro, J&J carved out rights to the drug in prostate cancer. GSK then bought out Tesaro in 2019. The ...
- Source: drugdu
- 118
- August 16, 2023
CS Pharmaceuticals snaps up AxeroVision to shore up ophthalmology portfolio

CS Pharmaceuticals (CSP) has acquired AxeroVision for an undisclosed fee, in a move that will involve a dry eye disease (DED) candidate being transferred over to the UK-based ocular therapeutics company. CSP, which is headquartered in London but develops and commercialises treatments for eye diseases in China, will continue developing AXR-270, a selective glucocorticoid receptor agonist. The drug has been in a phase of developmental dormancy. In August 2021, AxeroVision released positive Phase II results for the candidate in 129 patients with DED with meibomian gland dysfunction (MGD). In a statement announcing the 2021 results, AxeroVision – which spun out from GSK in 2016 – said it was planning to enrol around 800 patients in a Phase III trial comparing the eye cream with a vehicle, and a new drug application/marketed authorisation application filing expected in 2024. However, the company did not issue any further updates on the drug since ...
- Source: drugdu
- 169
- August 4, 2023
Bavarian Nordic Drops Out of RSV Vaccine Race with Phase III Flop

Pictured: Respiratory syncytial virus vial and syringe/iStock, Manjurul Bavarian Nordic’s portfolio has taken a hit as the company announced Saturday its respiratory syncytial virus vaccine candidate did not meet all primary endpoints in a Phase III study in older adults. While the vaccine candidate showed 59% efficacy in preventing at least two pre-defined lower respiratory tract disease (LRTD) symptoms from RSV, that number dropped to below the co-primary endpoint for severe LRTD in patients 60 and older. With the miss, Bavarian Nordic is discontinuing its RSV program. The decision also terminates its partnership with Nuance Pharma and chance for the coupled milestone payments of 195 million Danish kroner for developing and launching in select Asian markets. Bavarian Nordic CEO Paul Chaplin said in the release that the outcome was “unexpected” and will impact short-term growth expectations. However, the company said there is no impact on the financial guidance ...
- Source: drugdu
- 117
- July 26, 2023
Haleon Plots Massive Layoffs in UK and Beyond to Save Cost

Almost exactly one year after GSK’s consumer healthcare business spun out on its own as Haleon, the company is reportedly looking to save costs with sweeping layoffs across the board.Hundreds of jobs in the U.K. and potentially thousands worldwide are on the chopping block, The Guardian reports. Currently, Haleon’s U.K. headcount totals approximately 1,700 and its global workforce is made up of around 24,000 employees across 170 countries.Staffers were informed of the cuts through a series of meetings this week, according to the British newspaper. A consultation process began Wednesday and will run through August 25, after which some employees will be offered other roles at the company and others will split in September, according to The Guardian. The move is chalked up to Haleon’s larger cost-cutting program as the company looks to become a “more agile, productive and efficient organization” and to save 300 million pounds ($393 million) over the next ...
- Source: drugdu
- 326
- July 17, 2023
Gates Foundation and Wellcome to fund late-stage trial of tuberculosis vaccine candidate

The Bill & Melinda Gates Foundation and Wellcome have joined forces to fund the late-stage development of what could be the first tuberculosis (TB) vaccine in over a century. TB is a bacterial infection spread by inhaling tiny droplets from the coughs or sneezes of an infected person. Despite being both curable and preventable, the disease continues to affect around ten million people every year, and 1.6 million people died from it in 2021, almost entirely in low and middle-income countries. The only TB vaccine in use today, bacille Calmette-Guérin (BCG), was first used in 1921. It helps protect babies and young children against severe systemic forms of TB, but offers limited protection against pulmonary TB – a form of active TB – among adolescents and adults. The Gates Foundation and Wellcome will invest around $550m to support the phase 3 trial of the M72/AS01E (M72) vaccine, which will be ...
- Source: drugdu
- 120
- July 2, 2023
Biogen Shareholders Elect Susan Langer to Board of Directors Despite Controversy

By Tristan Manalac Pictured: A Biogen building/courtesy of PictureDesignSwiss/shutterstock After a June 12 shakeup of Biogen’s board of directors that included three directors foregoing their re-election, the company announced Monday that shareholders elected Susan Langer, who currently serves as president of Souffle Therapeutics, to the board. Langer will serve on the board for a one-year term, according to the press release. She was nominated by Alex Denner, a former member of the board who did not stand for re-election. According to reporting by Endpoints News and STAT News, Langer is Denner’s romantic partner and the mother of his child. BioPharma Dive reported that during Monday’s annual meeting of stockholders, Biogen management was asked why the company didn’t disclose this potential conflict of interest. Caroline Dorsa, the new chair, replied that Langer’s “personal matters obviously are much less relevant than what she brings to this board.” Langer has previously worked at ...
- Source: drugdu
- 134
- June 28, 2023
FDA Puts Mersana’s Ovarian Cancer Trials on Partial Clinical Hold

By Tristan Manalac www.biospace.com Pictured: FDA Building/courtesy of Grandbrothers/Adobe Stock The FDA has placed Mersana Therapeutics’ UP-NEXT and UPGRADE-A trials on partial clinical hold, the company announced Thursday. Both studies evaluate Mersana’s investigational antibody-drug conjugate upifitamab rilsodotin in platinum-sensitive ovarian cancer. The regulatory pause was triggered by an aggregate safety report containing information from around 560 patients who had received upifitamab rilsodotin (UpRi). Mersana’s data showed a higher rate of serious bleeding events, though most of these episodes were low-grade. Still, five cases of serious bleeding were fatal. The exact causes of bleeding are still unknown and are currently being investigated. Mersana’s stocks fell 60% in pre-market trading Thursday in response to the news. The FDA has yet to provide Mersana with a formal written communication regarding the partial clinical hold. However, the company expects the regulator to request a more comprehensive evaluation of UpRi’s safety data. Mersana is working ...
- Source: drugdu
- 103
- June 17, 2023
Biogen Makes Changes to Board of Directors Ahead of Annual Shareholder Meeting

By Tristan Manalac Pictured: A Biogen building/courtesy of PictureDesignSwiss/shutterstock Biogen announced Monday that three of its directors—Alexander Denner, William Jones and Richard Mulligan—will not stand for re-election at the company’s annual stockholder meeting Wednesday. Instead, Susan Langer will be up for election to Biogen’s board of directors. This latest shake-up comes after board chair Stelios Papadopoulos announced he was stepping down from his post after the annual meeting. Papadopoulos will be succeeded by Caroline Dorsa, a long-standing member of Biogen’s board who had previously served for more than two decades at Merck. Meanwhile, Langer is currently serving as president of Souffle Therapeutics, a privately held start-up that has most recently scored $50 million in investments, according to PitchBook. Before that, Langer was also the founding president of Kojin Therapeutics and the founding chief business officer of Paratus Sciences. She also previously worked at Biogen in posts of increasing responsibility. Endpoints ...
- Source: drugdu
- 114
- June 15, 2023
Sanofi, AstraZeneca’s RSV antibody for infants easily clears FDA adcomm, likely setting up approval

Seeking to launch their respiratory syncytial virus (RSV) prevention antibody for infants later this year, Sanofi and AstraZeneca have cleared one more regulatory hurdle.Thursday, experts on the FDA’s Antimicrobial Drugs Advisory Committee voted 21 to 0 that nirsevimab boasts a favorable benefit-risk profile to protect against RSV-associated lower respiratory disease in infants born during or entering their first RSV season. On a separate question of whether the drug has a favorable benefit-risk profile in children up to 24 months of age who remain vulnerable through their second RSV season, the vote was 19 to 2 in favor of the drug. “Most babies hospitalized with RSV are born at term and healthy, which is why interventions specifically designed to protect all infants are likely to result in the greatest impact,” Sanofi’s executive vice president of vaccines, Thomas Triomphe, said in a Thursday statement. “We are encouraged by the Advisory Committee’s positive ...
- Source: drugdu
- 165
- June 10, 2023
After selling Rubraca, Clovis Oncology unveils CRL for potential label expansion

Paul Schloesser Associate Editor Clovis Oncology is facing yet another setback with the FDA giving the battled company a complete response letter and rejecting a potential label expansion for its PARP inhibitor Rubraca. A new SEC filing Friday detailed how it received the CRL from the FDA on May 26, rejecting an sNDA for Rubraca as a first-line maintenance treatment for women with advanced ovarian cancer who are in complete or partial response to a first-line, platinum-based chemotherapy. FDA said that for the agency to reconsider the application, per the filing, Clovis would need to show results from an overall survival analysis that “do not demonstrate a potential OS detriment.” In the meantime, Clovis said that the FDA’s determination would impact the timing and achievability of milestone payments that Clovis is owed. The company sold rights to its PARP inhibitor to Swiss company pharma& Schweiz GmbH in an April deal ...
- Source: drugdu
- 204
- June 7, 2023

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