Search Results for “FDA” – Page 115 – media

InnoCare Announces First Prescription of Tafasitamab in Combination with Lenalidomide for Relapsed or Refractory Diffuse Large B-Cell Lymphoma Under Greater Bay Area’s Early Access Program

BEIJING, China. Jan. 22, 2024 – InnoCare (HKEX: 09969; SSE:688428) today announced that tafasitamab (Minjuvi®) in combination with lenalidomide has been recently approved by the Medical Products Administration of Guangdong Province, under the early access program in Guangdong-Hong Kong-Macao Greater Bay Area (“Greater Bay Area” for short), for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT). Through this program, the first prescription of tafasitamab in combination with lenalidomide was filled today at the Guangdong Clifford Hospital for an eligible DLBCL patient. The early access program of the Greater Bay Area allows designated medical institutions in the area to access drugs and medical devices that have been approved by regulatory authorities for marketing in Hong Kong or Macao.Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said, “We are pleased to provide eligible patients access ...
- Source: drugdu
- 154
- January 23, 2024
Comanche raises $75m to develop preeclampsia therapy

US-based Comanche Biopharma has raised $75m in an oversubscribed Series B financing round to develop its small interfering RNA (siRNA) therapy, CBP-4888, as a treatment for preeclampsia. The financiers included Google Ventures, F-Prime Capital, Lilly Asia Ventures, Longview Healthcare Ventures, New Enterprise Associates (NEA), and Atlas Venture. Furthermore, Scott Gottlieb from NEA and David Grayzel from Atlas will join Comanche’s board. Preeclampsia is persistent high blood pressure that develops during the second trimester of pregnancy or up to six weeks following delivery. It can be associated with high levels of proteins in the blood, decreased blood platelets, fluid in the lungs, or seizures. It occurs in 2-9% of pregnancies and the only management is premature delivery. Recent studies have found that excess circulating placental soluble fms-like tyrosine kinase 1 (sFlt1) is present in patients with preeclampsia, and can therefore, contribute to its pathogenesis. A 2023 study found that the administration ...
- Source: drugdu
- 93
- January 22, 2024
Synendos set to study endocannabinoid inhibitor for neuropsychiatric conditions

Swiss company Synendos therapeutics has been given the go-ahead from the European Medicines Agency (EMA) to advance its lead candidate, SYT-510, into a Phase I clinical trial to treat neuropsychiatric disorders. The first-in-class inhibitor targets endocannabinoids—naturally occurring, lipid-based neurotransmitters that help to maintain homeostasis. SYT-510 is said to inhibit endocannabinoid reuptake, which raises the amount of those neurotransmitters available in the synaptic cleft and increases neurotransmission. In the upcoming planned Phase I first-in-human trial, the focus will be on assessing the safety, tolerability and pharmacokinetics in healthy patients receiving increasing single doses of SYT-510. Basel headquartered-Synendos was spun out of the University of Bern in 2019, raising $27.8m in two Series A funding rounds in 2020 and 2021, co-led by Kurma Partners, Sunstone Life Science Ventures, and Ysios Capital. The company secured a two-year Eurostars grant in 2021, a European Union (EU) funding scheme, named the EndoCARE programme, to propel ...
- Source: drugdu
- 82
- January 22, 2024
Merck’s Keytruda again bags industry-first cervical cancer nod—with limitation

After crowning Keytruda as the first immunotherapy for advanced cervical cancer back in 2021, the FDA has awarded the drug another industry-first designation in an earlier stage of the tumor type. But again, the achievement was not perfect for Merck. Thanks to a new FDA nod, Merck’s Keytruda is the first PD-1 drug to be approved in combination with chemoradiotherapy to treat patients with stage 3 to 4a cervical cancer, the New Jersey pharma giant said Friday. This marks Keytruda’s 39th indication in the U.S. The approval, however, was narrower than expected. It came on the back of results from the Keynote-A18 trial, which showed a tumor progression benefit for the Keytruda-chemoradiation regimen in a broader patient population with earlier-stage cervical cancer. Keynote-A18 tested the Keytruda combo in patients whose cancer was as early as stage 1b2. Among the entire trial population, adding Keytruda to chemoradiotherapy slashed the risk of ...
- Source: drugdu
- 88
- January 21, 2024
report

Pharma giant AstraZeneca will spend $26.5 million to build a new production line for its diabetes treatments dapagliflozin and metformin hydrochloride at the Taizhou National Medical High-tech Development Zone in Jiangsu, China Daily reports. The facility is forecast to have an annual output value of $1.4 billion and is expected to become a global manufacturing outpost for the company’s diabetes therapies, according to the publication. Marketed in the U.S. as Farxiga, dapagliflozin helps prevent absorption of glucose in the kidneys to help lower blood sugar. Metformin, meanwhile, reduces the absorption of sugar from the stomach. As a combination therapy, the medicines are marketed as Xigduo. Fierce Pharma Manufacturing has reached out to AstraZeneca for additional details on the project. AstraZeneca’s operations in China were the focus of market speculation last summer when the Financial Times reported that the company had explored separating its business in the country amid increasing geopolitical ...
- Source: drugdu
- 131
- January 20, 2024
Lundbeck launches ‘Say Yep’ for new Vyepti multi-media migraine campaign

Lundbeck wants migraine suffers to say “nope” to doing more and “yep” to doing less with their condition as the core message of its new campaign for Vyepti. The “Say Yep” initiative plays on the yep in Vyepti, the pharma’s intravenous migraine prevention therapy that was approved by the FDA exactly four years ago next month. The therapy brought in DKK 1 billion ($145.9 million) in 2022, double what it made in 2021 and driven by what Lundbeck said was “strong demand.” The multi-channel media campaign is trying to reach the 40 million Americans who suffer from the often-debilitating condition. The message is to slow down and not push through the pain of a migraine. The campaign “brings to life the brand’s empathetic understanding that people are doing a lot to manage migraine and deserve to do a little less, if possible,” a spokesperson from Lundbeck said. “Say Yep subtly ...
- Source: drugdu
- 138
- January 20, 2024
Bayer CEO Bill Anderson makes his mark with major restructuring, ‘significant’ job cuts

Bayer is launching a sweeping business overhaul as the German conglomerate sees “no viable alternative.” Bayer on Wednesday unveiled a restructuring of its organization that will “come at the expense of many managerial employees,” according to chairwoman of the executives committee on Bayer’s supervisory board, Barbara Gansewend. The job cuts will begin in the coming months and will end in 2025, the company said without providing a specific number for the jobs impacted. But the reductions will be “significant” at the group in Germany, the company said. Bayer declined to comment on the scale of the layoff or the functions involved. Reducing bureaucracy is the “central component” of the adjustments, a Bayer spokesperson told Fierce Pharma. The company’s new operating models are developed with customers at the center. “For this reason, there are no top-down targets and we will only gradually know what scale is really realistic here,” the spokesperson ...
- Source: drugdu
- 183
- January 20, 2024
Gearing Up to Challenge Pfizer in a Rare Disease, BridgeBio Secures Up to $1.25B

BridgeBio will receive $500 million in exchange for royalties from sales of acoramidis, a drug currently under FDA review for treating heart complications caused by the rare disease transthyretin amyloidosis. The deal also refinances lending agreements, providing BridgeBio with access to additional capital. By FRANK VINLUAN BridgeBio Pharma is preparing to compete against a blockbuster Pfizer product for a rare disease with few treatment options. A new financing deal provides the company with the capital to support planned commercialization of its drug, which is currently under FDA review. The agreement announced Thursday calls for Blue Owl Capital and Canada Pension Plan Investment Board to pay BridgeBio $500 million cash in exchange for royalties of 5% from sales of the biotech’s drug, acoramidis. The deal provides the Palo Alto, California-based biotech an additional $450 million in committed capital by refinancing its lending agreement with Blue Owl. The company could also receive ...
- Source: drugdu
- 167
- January 20, 2024
Coya stretches lead drug’s development to Parkinson’s and dementia

Coya Therapeutics is expanding its development plans to study the company’s lead combination therapy COYA-302 in frontotemporal dementia and Parkinson’s disease in addition to amyotrophic lateral sclerosis (ALS) This follows the announcement of successful pre-IND and Type C meetings between Coya and the US Food and Drug Administration (FDA) earlier this month about the candidate. The company plans to file an IND for developing the drug in frontotemporal dementia in Q2 2024 and start a Phase II study the same quarter. The plans for studying COYA-302 in Parkinson’s will follow later, with an IND filing and a Phase I/II start proposed in 2025. In a deal worth up to $677.25m, Dr Reddy’s Laboratories had signed a licence agreement with Coya in December to develop and commercialise COYA 302 to treat ALS in the European Union (EU), the UK, the US and Canada. Under the terms of the agreement, Coya can ...
- Source: drugdu
- 117
- January 19, 2024
J&J, AZ/Daiichi Sankyo cancer therapies lead Clarivate’s annual rundown of notable new meds

Two cancer therapies have topped Clarivate Analytics’ Drugs to Watch in 2024, an annual report that identifies potential blockbusters and other medicines that could “transform treatment paradigms.” Clarivate predicts Johnson & Johnson’s combination treatment Akeega and Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan will generate $2.7 billion in sales each in 2029. On the list of 15 transformative medicines, these are the only ones expected to exceed $2 billion in sales by 2029. Clarivate’s report, which is in its 12th year, highlights drugs that have recently been approved or are expected to be approved in 2024. Its sales estimates cover the G7 countries—U.S., U.K., Japan, France, Italy, Germany and Canada. J&J was the only company with more than one drug on the list. Clarivate also spotlighted J&J’s Talvey, a first-in-class bispecific antibody to treat multiple myeloma. The analysts forecast Talvey’s sales will reach $850 million in 2029. The only other cancer ...
- Source: drugdu
- 149
- January 19, 2024

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