Search Results for “Novartis” – Page 22 – media

Genentech CEO Hardy warns of ‘unintended consequences’ from the Inflation Reduction Act

It’s been almost one year since Congress and the Biden administration passed the Inflation Reduction Act (IRA), and so far leaders in the biopharma industry have not been shy in voicing their complaints. As some drug companies and trade groups take to the courts with their arguments, Genentech CEO Alexander Hardy is publicly warning about the “unintended consequences” of the IRA. In a recent interview with Fierce Pharma, the Genentech chief described his concerns with measures included in IRA, which particularly affects the oncology sector, he says. Under the IRA, small molecule drugs are subject to Medicare drug-pricing negotiations after 9 years, while biologics get 13 years on the market before they’re included in the program. Regardless of a drug’s classification, Hardy noted that those timelines squeeze companies as they work to study their drugs in additional indications and reach more patients. Companies like Genentech regularly work to move their ...
- Source: drugdu
- 106
- July 10, 2023
Sandoz launches high-concentration biosimilar of AbbVie’s Humira in the US

Sandoz, a Novartis division, has announced the US launch of its citrate-free high-concentration formulation (HCF) of Hyrimoz (adalimumab-adaz) – a biosimilar version of AbbVie’s Humira (adalimumab). Hyrimoz HCF (100mg/mL) is approved to treat all indications that are no longer covered by the reference medicine regulatory exclusivity, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis and hidradenitis suppurativa. Biosimilars, according to the US Food and Drug Administration (FDA), are biological products that are highly similar to an existing FDA-approved reference product. The drugs have no clinically significant differences in terms of safety or effectiveness from the reference product, but they potentially lower healthcare costs. Hyrimoz was approved by the FDA in 2018 at a concentration of 50mg/mL. The HCF offers a 50% reduction compared to the original concentration and can decrease the number of injections required for people who need at least 80mg ...
- Source: drugdu
- 116
- July 7, 2023
FDA approves Skyline Therapeutics’ IND for macular degeneration trial

Chinese gene therapy company Skyline will initiate a global trial investigating a gene therapy to treat neovascular age-related macular degeneration (nAMD), after receiving clearance from the US Food and Drug Administration (FDA). The FDA granted the company’s investigational new drug (IND) application for a Phase I/IIa trial of SKG0106 – a one-time intravitreally delivered adeno-associated virus (AAV) gene therapy. Skyline has not disclosed when it expects to initiate the trial. Skyline Therapeutics’ candidate encompasses a new AAV capsid and unique transgene genome encoding an anti-VEGF protein. Vascular endothelial growth factor (VEGF) is a protein that promotes the growth of new blood vessels and also makes vessels more permeable or leaky. Patients with macular degeneration secrete too much of this protein. The company’s anti-angiogenic treatment is able to suppress neovascular lesions at a low dose with durable effects from a single injection. The prevention of neovascularisation provides relief of vascular leakage ...
- Source: drugdu
- 111
- July 6, 2023
Bayer needs ‘midsize acquisition’ to reach $10B oncology sales goal, exec says

Bayer recently laid out its ambition to achieve $10 billion in sales from its oncology business by 2030 and become a top 10 cancer drug player. To get there, the company is looking outside for a “midsize acquisition,” Bayer’s oncology chief Christine Roth said.Right now, Bayer’s Nubeqa leads the charge in the company’s oncology department, with its sales projected to peak at more than 3 billion euros. In addition, the company’s acquisitions of Vividion Therapeutics, BlueRock Therapeutics and Noria Therapeutics in recent years have bolstered its research capabilities. “We’ve done a lot of activity to fill our early pipeline,” Roth said in an interview with Fierce Pharma on the sidelines of the American Society of Clinical Oncology’s 2023 annual meeting. “But if we want to achieve that top 10 spot in the next four to six years, it’s going to take the right midsize acquisition to get there.” Roth agreed ...
- Source: drugdu
- 116
- June 15, 2023
Bristol Myers’ cell therapy manufacturing site in Massachusetts is good to go, FDA says

With two cell therapies approved and three more in its pipeline, Bristol Myers Squibb is working to beef up its manufacturing capabilities for the complex, personalized, one-and-done medicines.On Thursday, BMS took a positive step in that direction as the FDA gave the go-ahead for the company to begin commercial cell therapy manufacturing at its sprawling facility in Devens, Mass. The cell therapy portion of the Devens site includes 244,000 square feet and has been under construction since 2021. It becomes BMS’ third commercial CAR-T manufacturing facility in the U.S. and adds more than 500 new cell therapy jobs. It is the second significant expansion of the Devens complex, which sits on 89 acres of land and covers 700,000 square feet and has been operational for more than a decade. BMS’ cell therapies, Abecma and Breyanzi—both for blood cancers—were approved a month apart in early 2021. Abecma pulled in sales of ...
- Source: drugdu
- 107
- June 13, 2023
’ Seagen CEO talks about his next stop, Pfizer deal and the ADC landscape

David Epstein’s short tenure as Seagen’s CEO will likely end soon with the antibody-drug conjugate specialist’s sale to Pfizer. After a rich career spanning companies of various sizes, Epstein is keeping an open mind about where he might head next.“I will hopefully make new drugs somewhere else,” Epstein said in a recent interview on the sidelines of the American Society of Clinical Oncology’s annual meeting. “I don’t know where that will be.” Throughout his time in biopharma, Epstein has worn many hats. He’s known for building Novartis’ oncology unit and leading the Swiss giant’s larger global pharma business. He fostered startups for five years at Flagship Pioneering before taking the reins at Seagen in November. Those roles have given him experience in almost every therapeutic area and in both drug development and commercialization. That kind of resume opens a lot of possibilities—although going back to Flagship isn’t his plan right ...
- Source: drugdu
- 186
- June 10, 2023
Eisai hit with ransomware attack, launches investigation into possible data leaks

Eisai is the latest drugmaker to be hit with a ransomware attack.The Japanese company said it “immediately” set up a company-wide task force after suffering a cyberattack Saturday night. Now, it’s working to respond with external experts and law enforcement officials, Eisai said in a statement. The possibility of data leaks is currently under investigation, the company said. Eisai expects it will take “some time to gauge the full extent of the incident.” During the response, Eisai took some of its computer systems, both inside and outside of Japan, offline. For now, its corporate websites and email systems remain operational. As for the impact on the company’s earnings, Eisai is “carefully examining” any potential impact on its earnings forecast and will announce “as soon as possible” if revisions are necessary. Japan has seen an increasing amount of cyberattacks recently, according to The Japan Times. An official at the National Center ...
- Source: drugdu
- 131
- June 8, 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
Coherus, Junshi eye FDA finish line after agency finally conducts plant inspection

It’s been a long road for PD-1 partners Coherus BioSciences and Junshi Biosciences since their FDA rejection for cancer drug toripalimab more than a year ago, but the companies appear to be nearing the regulatory finish line in the U.S.Wednesday, Coherus said in a Securities and Exchange Commission filing that the U.S. FDA “successfully completed the required pre-licensing inspection” of Junshi’s manufacturing site in China. The FDA made three observations about plant deficiencies, but Coherus believes those are “readily addressable.” The partners plan to submit their response to the FDA in the coming weeks. Coherus says it’s planning to launch toripalimab in the U.S. after a potential FDA approval. The inspection comes after multiple regulatory delays. In May 2022, the FDA rejected the drug and requested a quality process change. At the time, the companies noted that a resubmission would take about six months because plant inspections had been delayed ...
- Source: drugdu
- 133
- June 5, 2023
Lung association calls for more Black Americans to join clinical trials in pharma-backed effort

Beth Snyder Bulik Senior Editor The American Lung Association is doubling down on efforts to encourage more Black Americans to join lung cancer clinical trials. The new pharma-sponsored “Awareness, Trust and Action” initiative aims to put those three words into action with a national campaign that includes digital posts and social media. The first posts are slated to go up on Saturday, which is Clinical Trials Awareness Day. Daiichi Sankyo, Genentech, Merck, Novartis and Novocure provided financial support for the project. Cedric “Jamie” Rutland “We have to do a better job of recruiting Black Americans into clinical trials and letting them know why,” said pulmonologist Cedric “Jamie” Rutland, a national volunteer medical spokesperson for the American Lung Association. “And not only that, but teaching Black Americans what lung cancer is, what the risk factors are, why they have risk factors living in heavily polluted areas … We have to ...
- Source: drugdu
- 119
- May 23, 2023

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