Search Results for “acquisition” – Page 14 – media

【EXPERT Q&A】Can veterinary drug API companies succeed in CDMO transformation?

Drugdu.com expert’s response: I agree that the success of a veterinary API (Active Pharmaceutical Ingredient) company’s transition to CDMO (Contract Development and Manufacturing Organization) hinges on both the potential for success and the crucial factors that contribute to it. Here’s a translation of your points into English: I. Potential for Successful Transition Market Demand: With the rapid development of the global pharmaceutical industry, the veterinary drug market has also shown a steady growth trend. The transition of veterinary API companies to CDMO can cater to the outsourcing needs in veterinary drug R&D and production, particularly for those lacking in-house R&D and manufacturing capabilities, making CDMO services all the more crucial. Technical Accumulation: Veterinary API companies have accumulated substantial technical experience and production capabilities through their manufacturing processes, which can be effectively leveraged during the transition to CDMO. By enhancing their R&D capabilities and service standards, these companies can offer higher-quality, ...
- Source: drugdu
- 102
- August 23, 2024
Johnson & Johnson Set to Acquire V-Wave Ltd

By Don Tracy, Associate Editor The acquisition, valued at $600 million, is expected to integrate V-Wave into Johnson & Johnson MedTech, which could improve the treatment of heart failure with reduced ejection fraction.Johnson & Johnson (J&J) has reached a definitive agreement to acquire V-Wave Ltd., a private company specializing in cardiovascular implants for heart failure patients. The acquisition is expected to integrate V-Wave into Johnson & Johnson MedTech. V-Wave was recently granted FDA Breakthrough Device Designation and CE mark approval for the Ventura Interatrial Shunt technology, which treats heart failure with reduced ejection fraction (HFrEF). The deal is expected to close by the end of this year.1 “We are excited to welcome V-Wave to Johnson & Johnson MedTech and to take another meaningful step toward transforming the standard of care for cardiovascular disease. We recognize the importance of identifying more diverse and effective treatments for heart failure, and our recent ...
- Source: drugdu
- 73
- August 22, 2024
Trends, Drivers, and Implications

Current trends are driven by various strategic and financial considerations from both established pharmaceutical companies and development-stage biotech firms. Understanding the valuation and accounting implications of these transactions are crucial for stakeholders to navigate the complex landscape effectively. By Kristen SeaverThe biotechnology industry has witnessed significant shifts in recent years, particularly in the realm of both mergers and acquisitions (M&A) and collaborative agreements. These trends are driven by various strategic and financial considerations from both established pharmaceutical companies and development-stage biotech firms. Understanding the valuation and accounting implications of these transactions are crucial for stakeholders to navigate the complex landscape effectively. Trends in biotech transactions One of the prominent trends in the biotech sector is the acquisition of clinical-stage companies with compelling clinical development programs. Established pharmaceutical companies are increasingly acquiring development stage companies with promising clinical stage programs to bolster their drug development pipelines and mitigate the risks associated ...
- Source: drugdu
- 88
- August 17, 2024
Gilead’s PBC therapy Livdelzi bags accelerated approval

Gilead Sciences’ Livdelzi (seladelpar) has received an accelerated approval from the US Food and Drug Administration (FDA) to treat primary biliary cholangitis (PBC). The approval is based on results from the Phase III RESPONSE trial (NCT04620733), which demonstrated Livdelzi to be the first treatment yielding significant reductions in alkaline phosphatase (ALP) normalisation and pruritus—significant markers of PBC progression. ALP levels normalised at 12 months for 25% of Livdelzi-treated patients compared to none on placebo. Change in pruritus score at six months was significantly reduced among Livdelzi-treated patients compared to those taking placebo. Overall, 62% of patients on Livdelzi achieved composite biochemical response at 12 months, achieved by just 20% of placebo patients. With this regulatory nod, Livdelzi enters a space dominated by other approved therapies like Ocaliva (obeticholic acid) and ursodeoxycholic acid. Ocaliva was developed by Intercept Pharmaceuticals, which was acquired by Alfasigma in late 2023. Gilead gained the rights ...
- Source: drugdu
- 66
- August 17, 2024
FDA Awards Accelerated Approval to Gilead Sciences Drug for Rare Liver Disease

Livdelzi is now FDA-approved for treating the rare liver disease primary biliary cholangitis. Gilead Sciences added the drug to its pipeline via the $4.3 billion acquisition of CymaBay Therapeutics earlier this year. By Frank Vinluan A Gilead Sciences drug acquired earlier this year in a multi-billion dollar deal is now FDA approved as new treatment for primary biliary cholangitis (PBC), a rare liver disease that can lead to liver failure. The approval announced Wednesday for the drug covers the treatment of adults whose disease is inadequately managed by the standard of care PBC drug as well as those who cannot tolerate that drug. The Gilead therapy, seladelpaar, will be marketed under the brand name Livdelzi. PBC is a rare, progressive autoimmune condition that leads to inflammation and scarring of the liver’s bile ducts. The chronic disorder, which impairs liver function, mainly strikes women over 40 years of age. Gilead estimates that ...
- Source: drugdu
- 78
- August 16, 2024
Buyout of China’s drug companies by global pharma giants sparks national security fears

Chinese pharmaceutical industry insiders have warned that foreign takeovers may damage the sector and even threaten national security. Since December, five Chinese biotech drug makers have been sold to global pharmaceutical giants. Industry insiders have warned that this could have a negative impact, especially given the risk that the United States could extend its technology sanctions to essential medicines. John Cai, chairman of China Healthcare Innovation Platform Academy, a healthcare think tank in Shanghai, said: “When national conflicts occur and drugs are sanctioned as strategic products, it will affect the health of a country’s population. “Considering that China’s biopharmaceutical and broader healthcare industry are now facing international competition and restrictions, Beijing should act with a sense of urgency.” He also said that research and development was a long process and if innovative products were sold as soon as they were developed, it would be difficult for China to cultivate world-class ...
- Source: drugdu
- 63
- August 8, 2024
Otsuka Commits $800M in M&A Deal Bringing a Phase 3-Ready Metabolic Disorder Drug

Otsuka Pharmaceutical is acquiring Jnana Therapeutics, whose lead drug is a potential treatment for the rare metabolic disorder phenylketonuria (PKU). Jnana’s drug could provide an alternative to two FDA-approved PKU medicines from BioMarin Pharmaceutical. By Frank VinluanOtsuka Pharmaceutical is broadening its scope in rare disease, striking a deal to acquire Jnana Therapeutics and its lead drug candidate, a small molecule on track for pivotal testing in a metabolic disorder with few treatments. Per deal terms announced Thursday, Otsuka is paying $800 million up front to buy Boston-based Jnana. The Japanese pharma company could shell out up to $325 million more if the lead drug candidate of privately held Jnana achieves development and regulatory milestones. Jnana’s lead program, JNT-517, is in development for phenylketonuria (PKU), an inherited disorder that leads to deficiency of an enzyme needed to break down phenylalanine, an amino acid found in certain foods. Buildup of phenylalanine in ...
- Source: drugdu
- 93
- August 5, 2024
Otsuka snaps up Jnana with its phenylketonuria drug for $800m

Otsuka Pharmaceutical is looking to acquire US-based Jnana Therapeutics in a deal worth up to approximately $1.1bn. The Japanese company will pay Jnana’s shareholders $800m through its US subsidiary, Otsuka America. Jnana will also be in line to receive up to $325m in milestone-based payments. The deal is expected to close in Q3 this year. Otsuka plans for Jnana to operate as its subsidiary following the acquisition. To achieve this, it plans to merge Jnana with a special purpose company, established under Otsuka America, with the Jnana remaining as the surviving company. Jnana’s lead asset is JNT-517 being developed to treat phenylketonuria (PKU), a rare inherited metabolic disorder that causes an amino acid called phenylalanine to build up in the body. JNT-517 inhibits SLC6A19 or solute carrier family 6 member 19, a transmembrane protein that regulates phenylalanine absorption and reuptake in the small intestine and kidney. In June, Jnana reported ...
- Source: drugdu
- 107
- August 3, 2024
Biotech Startup AIRNA Adds $60M to Advance RNA-Editing Therapy for Rare Protein Deficiency

AIRNA’s therapy for alpha1 antitrypsin deficiency, or AATD, edits RNA to address the underlying cause of this rare inherited disease. Wave Life Sciences and Korro Bio are both further along in the development of RNA-editing therapies for AATD, but AIRNA claims its therapy could be best in class. By Frank VinluanA particular protein deficiency that leads to liver and lung damage is currently treatable only with decades-old therapies that all have limitations. Biotech startup AIRNA is part of a field of companies developing novel treatments for this inherited disorder, and it aims to stand apart with a genetic medicine it contends could become best in class. AIRNA is preparing to advance this program to clinical testing and on Wednesday it revealed a fresh round of $60 million to support its plans. The disease that Cambridge, Massachusetts-based AIRNA aims to treat is alpha-1 antitrypsin deficiency, or AATD. This rare disease, affecting ...
- Source: drugdu
- 66
- August 3, 2024
With FDA Nod for Colorectal Cancer Screening, How Much Market Share Can Guardant’s Blood Test Get?

Guardant Health’s Shield, a liquid biopsy that screens for colorectal cancer by analyzing a patient blood sample, will compete against stool-based tests already established in the market. Shield could also face new competition from other liquid biopsy companies. By Frank Vinluan FDA approval of a Guardant Health blood test that screens for colorectal cancer makes it the first liquid biopsy approved for this type of cancer, clearing the way to make this test more accessible to more people. But commercialization will be a challenge as the new test is not expected to become the first or even second screening option for patients. The approval announced Monday for the test, named Shield, covers the screening of adults age 45 and older at average risk for colorectal cancer. Colorectal cancer is the third most common type of cancer in the U.S., excluding skin cancers, according to the American Cancer Society. For men and women combined, it’s ...
- Source: drugdu
- 112
- August 1, 2024

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