PharmaFocus Today – Page 181 – media

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
- 135
- 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
- 140
- January 20, 2024
With manufacturing-related rejection, FDA turns its nose up at Satsuma’s migraine nasal spray

Considering trial setbacks and cash concerns, Satsuma Pharmaceuticals faced an uphill climb to even file for approval of its migraine spray treatment at the FDA. Now, the agency has thrown another wrench in the company’s commercial hopes by issuing a manufacturing-related complete response letter. In rejecting the application, the agency cited chemistry, manufacturing and controls concerns, Satsuma’s parent company, Shin Nippon Biomedical Laboratories, said in a press release. The agency did not flag issues with the clinical data package or request new trials. “We remain committed to working expeditiously with the FDA to complete the review for STS101 as soon as possible,” Satsuma’s CEO Ryoichi Nagata, M.D., Ph.D., said in the release. The company will detail potential timing for a resubmission after consulting with the FDA. The update is just the latest in a series of setbacks for Satsuma and its migraine asset, dubbed STS101. After coming up short two ...
- Source: drugdu
- 105
- January 20, 2024
After 17-year courtship, Sun and Taro finally agree on $348M buyout

It took 17 years for Sun Pharmaceutical and Taro Pharmaceutical to finally tie the knot. On Thursday, the companies revealed their long-awaited merger, with Sun of Mumbai, India, agreeing to purchase outstanding shares in the Israeli drugmaker for $43 each. The deal nets out to $348 million for a 48% premium on Taro’s share price of $29. Taro, which manufactures generics, over-the-counter drugs and APIs, will be delisted on the New York Stock Exchange and become a privately held subsidiary within Sun, which already had a 78.5% stake in the company. The companies expect the deal to close in the first half of this year. In its most recent financial report, Taro posted revenue of $593 million for the 12 months ending on Sept. 30, 2023, for a 4% increase year over year. Taro’s annual revenue has generally been in decline since maxing out in 2016 at $951 million. Sun ...
- Source: drugdu
- 162
- 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
- 185
- January 20, 2024
Bora plants its flag in the US with $210M acquisition of generics manufacturer Upsher-Smith

Taiwan-based CDMO Bora Pharmaceuticals is expanding its business in the United States, acquiring Minnesota generics manufacturer Upsher-Smith Laboratories for $210 million. Upsher-Smith, which was established in 1919, brings two manufacturing facilities that are five miles apart in the suburbs of Minneapolis. These become Bora’s first facilities in the U.S. Bora also has a 170,000 square meter plant in Mississauga, Ontario, which acts as its North America headquarters. Upsher-Smith produces a portfolio of 48 generic products. Its plants can handle packaging and a range of formulations including oral solids, liquids and topical powders. The sites have a total annual capacity of 3.5 billion doses. “This is a significant milestone for Bora Group, marking the most critical expansion of Bora’s presence in the U.S. market and significantly enhancing Bora’s position as a global competitor,” Bora CEO Bobby Sheng said in a release. The acquisition also supports Bora’s commercial prescription business, TWi, which ...
- Source: drugdu
- 99
- January 20, 2024
Brush Biopsy Test Detects Oral Cancer without Surgery

Oral squamous cell carcinoma, the most common type of oral cancer and globally the ninth most prevalent cancer, currently relies on surgical biopsies for diagnosis. This additional referral step poses the risk of losing patients who may not return for follow-up until the cancer has progressed to advanced, more challenging stages. Additionally, surgical biopsies can be problematic as they often collect a mix of cell types, complicating the analysis, and creating the risk of spreading cancerous cells to other parts of the mouth. General blood tests looking for cancer’s genetic signals also have limitations, as they do not specify the tumor’s location, preventing quick initiation of treatment after detection. Now, a new test that allows dentists to screen for oral squamous cell carcinoma with a simple brush could early detection of oral cancer without surgery. The diagnostic kit, created by researchers at the University of Illinois Chicago (Urbana, IL, USA), ...
- Source: drugdu
- 123
- January 20, 2024
One-Minute COVID-19 Test Adaptable For Detecting Other Viruses with Spike-Like Proteins

Several animals ranging from fireflies to lantern fish have the chemical tools needed to produce light. Such a reaction usually requires the substrate luciferin and the enzyme luciferase. However, a class of less discriminating luciferins, termed as imidazopyrazinone-type (IPT) compounds, has the ability to glow upon coming into contact with other proteins, including ones that are not considered to be enzymes. Previous studies have suggested that IPT luciferins could act as the basis for a new type of medical test that utilizes luminescence to indicate the presence of a target protein in a specimen. Now, a team of researchers has developed a glowing test, based on their belief that an IPT luciferin can react with the SARS-CoV-2 spike protein, which allows the virus particles to invade cells and cause COVID-19. In their research, the team at the National Institute of Advanced Industrial Science and Technology (AIST, Ibaraki, Japan) focused on ...
- Source: drugdu
- 96
- January 20, 2024
Bayer’s Cost-Cutting Plans Take Aim at Multiple Layers of Management

CEO Bill Anderson said despite prior cost-cutting measures, Bayer still has too many layers of management and bureaucracy. A new restructuring will come with layoffs but the corporate shakeup plan does not yet include a separation of Bayer’s business units. By FRANK VINLUAN Bayer is implementing a corporate restructuring that will slash an unspecified number of jobs, particularly within management. But the strategy does not include a breakup of the conglomerate—at least not yet. In announcing its new strategy late Wednesday, Bayer said it aims to reduce hierarchies and eliminate bureaucracy in the company. The job cuts will happen over the coming months and will be completed by the end of next year at the latest, the company said. Bayer’s corporate shakeup is not entirely a surprise. CEO Bill Anderson, who joined Bayer last June after serving as the chief executive of Roche’s pharmaceuticals division, has been critical of bloat ...
- Source: drugdu
- 118
- 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
- 174
- January 20, 2024

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