Search Results for “FDA” – Page 131 – media

Biogen Lays Off 113 Reata Employees Weeks After Completing $7B Acquisition

By Tristan Manalac Pictured: Biogen sign/The Boston Globe via Getty, John Tlumacki Biogen is laying off 113 employees from Reata Pharmaceuticals’ Plano, Texas site, according to a Worker Adjustment and Retraining Notification notice. The layoffs, set to take effect in late November, come just months after Reata was acquired by Biogen for $7.3 billion in July 2023. At the time, Biogen had just launched a sweeping cost-reduction program which involved terminating around 1,000 employees in an effort to save $1 billion in operating expenses by 2025. Late last month, Biogen completed the acquisition of Reata. In an emailed statement to Endpoints News, a Biogen spokesperson confirmed the job cuts which will mostly affect “roles where there are existing synergies at Biogen.” The positions include general and administrative services, as well as some development-focused jobs. “We are retaining those colleagues who have been essential to the launch of Skyclarys to ensure ...
- Source: drugdu
- 221
- October 14, 2023
Judge grants preliminary approval to Philips class action settlement

BY CHRIS NEWMARKER A federal judge in Pennsylvania has granted preliminary approval to an economic loss settlement involving lawsuits filed against Philips over its massive recall of CPAPs and other respiratory devices. U.S. District Court Judge Joy Flowers Conti’s order, filed yesterday, could just be the beginning of settling what has arguably been one of the medical device industry’s most serious recalls in recent decades. (Here is a full timeline of the Philips recall.) According to plaintiffs’ co-lead counsel, Philips has agreed to provide at least $479 million in compensation to device users who paid out of pocket to buy or rent the recalled devices, as well as payers who reimbursed users for the devices. Awards could range between $55.63 and $1,552.25 for each recalled device, plus a $100 award apiece for those who returned devices. “We are pleased that Judge Conti granted preliminary approval of the Philips economic loss ...
- Source: drugdu
- 156
- October 14, 2023
report

Antibodies and immunotherapies are all the rage in the lung cancer drug market, but older, small molecule drugs can still carve out a healthy niche-and AstraZeneca’s Tagrisso is set to be the leader in that market. That’s according to a new report out by analysts at GlobalData who see more than $7 billion in sales by 2029 for Tagrisso, a small molecule kinase inhibitor. It was first approved in 2015 for certain non-small cell lung cancer (NSCLC) patients with an EGFR mutation, later receiving a first-line green light in 2018 and an adjuvant approval in 2020. Tagrisso is AstraZeneca’s biggest-selling drug, making $5.44 billion in 2022, up 15% in 2021 and more than double its newer oncology drugs Imfinzi, an immunotherapy and PARP inhibitor Lynparza. “In the ever-evolving landscape of oncology, small-molecule drugs are carving a significant niche in lung cancer treatment,” said analysts at GlobalData. “Tagrisso is projected to ...
- Source: drugdu
- 176
- October 14, 2023
Biogen lays off staffers at newly acquired Reata, with 113 set to lose positions

Biogen just closed its Reata Pharmaceuticals buyout in September. Now, 100-plus Reata staffers are losing their jobs because their roles were already covered at the Massachusetts Big Biotech. That didn’t take long.Just two weeks after Biogen completed its buyout of Reata Pharmaceuticals, the combined company is trimming its staff. In a recent Worker Adjustment and Retraining Notification (WARN) notice sent to state officials in Texas, Reata said it’s cutting 113 positions. The layoffs will take effect late next month. Reata employed 321 people at the start of the year, an annual Securities and Exchange Commission filing (PDF) shows, so the layoffs are set to affect about a third of the acquired company’s staff. Biogen inked its Reata buyout in July, picking up the potential blockbuster Skyclarys, which is approved by the FDA to treat the rare, inherited neurological disorder Friedreich ataxia. The companies completed the deal in September. At the ...
- Source: drugdu
- 149
- October 13, 2023
Bayer christens $250M cell therapy ‘launch facility’ in Berkeley

Despite the promise of cell therapies, manufacturing the personalized medicines at scale has been a limiting factor for many companies. Now, as BlueRock Therapeutics advances its lead prospect, its parent company Bayer is ready to kick production into high gear.Bayer on Tuesday opened its first Cell Therapy Launch Facility in Berkeley, California, which is expected to create capacity to bring cell therapies to patients worldwide. Bayer has invested $250 million to build the plant, which will initially crank out materials for late-stage clinical trials across 100,000 square feet of space, the drugmaker said in a release. The plant is also equipped to support the potential commercial launch of BlueRock’s experimental cell therapy for Parkinson’s disease, bemdaneprocel. At the moment, BlueRock says planning is underway for its phase 2 study of bemdaneprocel, which is expected to start enrolling patients in the first half of 2024. The plant features flexible, modular space ...
- Source: drugdu
- 140
- October 12, 2023
Q&A With David Klein, Co-Founder and CEO of Click Therapeutics

Mike Hollan Klein discusses how recent FDA draft guidelines will impact the use of SaMD in the life sciences industry. David Klein CEO and co-founder Click Therapeutics FDA recently released draft guidelines regarding the use of software as a medical device (SaMD), which determines when the software should be included on the drug’s label. David Klein, CEO of Click Therapeutics, spoke with Pharmaceutical Executive about the impact these guidelines could have on the industry. Pharmaceutical Executive: What work are you doing with SaMD? David Klein: We are a science led biotech and tech company developing SaMD to be prescription treatments. That includes prescription digital therapeutics and discovering developing them in a way where they could potentially work independently or in conjunction with pharmacotherapies in order to lead to better clinical and economic outcomes. PE: The FDA just issued some updated guidelines regarding SaMD, how do you think the industry will ...
- Source: drugdu
- 176
- October 12, 2023
ABVC BioPharma obtains patent for MDD treatment in Taiwan

ABVC BioPharma has obtained a patent in Taiwan for the use of PDC-1421 in ABV-1504, an asset that treats major depressive disorder (MDD). PDC-1421 is an extract of Radix Polygala. In April 2023, the company received a patent for the same treatment in the US. Data from the latest studies showed that PDC-1421 should be given orally as a capsule for a minimum of 25 days. Doses ranged from once to three times per day. ABVC CEO Dr Uttam Patil stated: “These patents grant ABVC the right to exclude others from using, offering or selling PDC-1421 throughout the US and Taiwan until the year 2040. “As our patent map steps into global coverage, we eagerly await the results of patent applications in the European Union, China, Japan and more.” ABV-1504 is an inhibitor of norepinephrine transporter. The company has concluded Phase II clinical trials of ABV-1504 containing PDC-1421 and intends ...
- Source: drugdu
- 155
- October 11, 2023
Takeda to Pull Lung Cancer Drug from Market After Failed Confirmatory Study

Takeda Pharmaceutical drug Exkivity failed the confirmatory study required of its 2021 accelerated approval. Our recap of other recent regulatory developments includes a partial clinical hold on a cancer drug, a Covid-19 vaccine authorization, and several drug approvals in the U.S. and beyond. By FRANK VINLUAN Accelerated approval offers a way to more quickly bring patients drugs for diseases that have few treatment options. But that speedy path to the market comes with the understanding that the FDA can take its regulatory blessing away—unless the company takes its drug away first. That is what Takeda Pharmaceutical has decided to do with its cancer drug, Exkivity. Following discussions with the FDA, the Japanese pharmaceutical giant is voluntarily withdrawing Exkivity from the market. Exkivity treats non-small cell lung cancer by targeting epidermal growth factor (EGFR). That cancer protein must have exon 20 mutations—the same genetic signature addressed by Johnson & Johnson’s Rybrevant. ...
- Source: drugdu
- 196
- October 10, 2023
Ocular launches ocular implant trial to combat macular degeneration

US biopharmaceutical firm, Ocular Therapeutix has announced the start of its first clinical trial of an intravitreal eye implant intended to combat macular degeneration. Named OTX-TKI, the axitinib intravitreal implant is intended to treat wet age-related macular degeneration (wet AMD). Alongside the announcement the company has requested a Special Protocol Assessment (SPA) from the US Food and Drug Administration (FDA) as to how the trial is designed. Overall, the trial will recruit approximately 300 evaluable wet AMD patients. Antony Mattessich, CEO of Ocular Therapeutix said: “With the activation of our first clinical site in the US, we believe we are on target to enrol our first subject before year-end. “The trial is a crucial step forward for our clinical program as we make progress toward our goal of bringing a transformative new treatment that can truly make a difference for wet AMD to patients coping with vision loss.” The company ...
- Source: drugdu
- 169
- October 10, 2023
Ocular launches ocular implant trial to combat macular degeneration

US biopharmaceutical firm, Ocular Therapeutix has announced the start of its first clinical trial of an intravitreal eye implant intended to combat macular degeneration. Named OTX-TKI, the axitinib intravitreal implant is intended to treat wet age-related macular degeneration (wet AMD). Alongside the announcement the company has requested a Special Protocol Assessment (SPA) from the US Food and Drug Administration (FDA) as to how the trial is designed. Overall, the trial will recruit approximately 300 evaluable wet AMD patients. Antony Mattessich, CEO of Ocular Therapeutix said: “With the activation of our first clinical site in the US, we believe we are on target to enrol our first subject before year-end. “The trial is a crucial step forward for our clinical program as we make progress toward our goal of bringing a transformative new treatment that can truly make a difference for wet AMD to patients coping with vision loss.” The company ...
- Source: drugdu
- 144
- October 9, 2023

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