Research from Water Tower Research, Water Tower Research

Water Tower Research

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Water Tower Research is a leading equity research firm that provides research on micro, small and mid cap companies.

Water Tower Research was founded by Wall Street veterans after witnessing a fundamental shift in the investment research industry with the result being a declining knowledge base among investors, a lack of awareness and a shrinking pool of fundamental research being conducted on companies across the small-cap and micro-cap spectrum. The same issues are now increasingly occurring in the mid-cap space. This sea change within the investment community is impacting not only the companies themselves but also current shareholders and potential investors. With significantly less active sell-side sponsorship by Wall Street, a substantial information gap has developed between companies and various constituents in the financial community. The net result is fewer channels for insight and information to flow between companies and investors.

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<ul><li>FDA Commissioner Martin Makary injected some regulatory optimism with his first public comments, advocating for accelerated drug approval pathways.</li><li>While biopharma headlines were a roller coaster, investors appeared ready to grasp any positive news, despite more signs of FDA dysfunction.</li><li>In an E&amp;Y report reviewed by Reuters, 25% pharma tariffs would increase drug costs by $51 billion, leading to either 12.9% higher prices or reductions in R&amp;D efforts and workforce. </li></ul>

FDA Commissioner Martin Makary injected some regulatory optimism with his first public comments, advocating for accelerated drug approval pathways.While biopharma headlines were a roller coaster, investors appeared ready to grasp any positive news, despite more signs of FDA dysfunction.In an E&amp;Y report reviewed by Reuters, 25% pharma tariffs would increase drug costs by $51 billion, leading to either 12.9% higher prices or reductions in R&amp;D efforts and workforce. 

Biopharma Week in Review: Makary Sparked FDA Optimism; Growing Pushback on HHS Changes

Global Healthcare Analyst

Tina Banerjee

<ul>
<li>EMA’s human medicines committee (CHMP) recommended three new medicines for approval and adopted positive opinion for one generic medicine at its February 2025 meeting. </li>
<li>The committee recommended extending the therapeutic indications of 16 existing medicines, including two cystic fibrosis medicines, KAFTRIO and KALYDECO and oncology drugs CALQUENCE, DARZALEX, ENHERTU, and RINVOQ . </li>
<li>The CHMP concluded that its opinion recommending a marketing authorization for Eisai's Alzheimer’s disease drug Leqembi does not need to be updated.</li>
</ul>


EMA’s human medicines committee (CHMP) recommended three new medicines for approval and adopted positive opinion for one generic medicine at its February 2025 meeting. 
The committee recommended extending the therapeutic indications of 16 existing medicines, including two cystic fibrosis medicines, KAFTRIO and KALYDECO and oncology drugs CALQUENCE, DARZALEX, ENHERTU, and RINVOQ . 
The CHMP concluded that its opinion recommending a marketing authorization for Eisai's Alzheimer’s disease drug Leqembi does not need to be updated.


CHMP Meeting Update: 4 New Medicines Recommended For Approval, Reinstates Previous Leqembi Decision

<ul>
<li>In its January 2025 meeting, EMA’s human medicines committee (CHMP) recommended eight medicines for approval, including four innovative, three biosimilars, and one generic drugs.</li>
<li>The committee has also recommended extensions of indication for eight medicines that are already authorized in the EU.</li>
<li>Marketing applications for two medicines were withdrawn. Among them, withdrawal of Daiichi Sankyo’s datopotamab deruxtecan for non-squamous non-small cell lung cancer is noteworthy.</li>
</ul>


In its January 2025 meeting, EMA’s human medicines committee (CHMP) recommended eight medicines for approval, including four innovative, three biosimilars, and one generic drugs.
The committee has also recommended extensions of indication for eight medicines that are already authorized in the EU.
Marketing applications for two medicines were withdrawn. Among them, withdrawal of Daiichi Sankyo’s datopotamab deruxtecan for non-squamous non-small cell lung cancer is noteworthy.


CHMP Meeting Update: Eight New Medicines Recommended For Approval

<ul>
<li>Wuxi Biologics is selling its Ireland vaccine manufacturing facility to Merck for $500M. Astellas Pharma received approval for Vyloy in China for the first-line treatment of gastric cancer.</li>
<li>FDA decision for Otsuka’s label expansion application for brexpiprazole for the treatment of post-traumatic stress disorder will be delayed. EMA has accepted Otsuka’s marketing application for HAE drug candidate donidalorsen.</li>
<li>Samsung Biologics has extended collaboration with LigaChem Biosciences to provide ADC services. Pharmaessentia has announced positive topline results from phase 3 clinical trial of P1101 for Essential Thrombocythemia (ET).</li>
</ul>


Wuxi Biologics is selling its Ireland vaccine manufacturing facility to Merck for $500M. Astellas Pharma received approval for Vyloy in China for the first-line treatment of gastric cancer.
FDA decision for Otsuka’s label expansion application for brexpiprazole for the treatment of post-traumatic stress disorder will be delayed. EMA has accepted Otsuka’s marketing application for HAE drug candidate donidalorsen.
Samsung Biologics has extended collaboration with LigaChem Biosciences to provide ADC services. Pharmaessentia has announced positive topline results from phase 3 clinical trial of P1101 for Essential Thrombocythemia (ET).


APAC Healthcare Weekly (Jan 12)- Wuxi Biologics, Astellas, Otsuka, Samsung Biologics, Pharmaessentia

Articles from Caixin Global, Caixin Global

Caixin Global

Articles from Caixin Global

Caixin is a media group dedicated to providing financial and business news through periodicals, online content, mobile apps, conferences, books and TV/video programs. Caixin aims to blaze a trail that helps traditional media prosper in the new media age through integrated multimedia platforms.

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<ul><li>Lawsuits / In Depth: Why more Chinese companies are getting sued by aggrieved investors</li><li>China-Southeast Asia /Analysis: Why Southeast Asia is becoming a manufacturing hub for Chinese investments</li><li>Travel /: Surge in Chinese overseas tourism set for Lunar New Year</li></ul>

Lawsuits / In Depth: Why more Chinese companies are getting sued by aggrieved investorsChina-Southeast Asia /Analysis: Why Southeast Asia is becoming a manufacturing hub for Chinese investmentsTravel /: Surge in Chinese overseas tourism set for Lunar New Year

CX Daily: Why More Chinese Companies Are Getting Sued by Aggrieved Investors 

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Merck & Co., Inc.  is a global health care company that delivers health solutions through its prescription medicines, vaccines, biologic therapies, animal health, and consumer care products, which it markets directly and through its joint ventures. The Company has operations in pharmaceutical, animal health, and consumer care.

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Biopharma Week in Review: Makary Sparked FDA Optimism; Growing Pushback on HHS Changes

FDA Commissioner Martin Makary injected some regulatory optimism with his first public comments, advocating for accelerated drug approval pathways.

Water Tower Research

CHMP Meeting Update: 4 New Medicines Recommended For Approval, Reinstates Previous Leqembi Decision

EMA’s CHMP recommended three new and one generic medicines for approval at its February 2025 meeting. The committee concluded that its positive...

Tina Banerjee

CHMP Meeting Update: Eight New Medicines Recommended For Approval

In its January 2025 meeting, CHMP recommended 8 drugs for approval, including 4 innovative, 3 biosimilars, and 1 generic drugs. The committee has...

Tina Banerjee

APAC Healthcare Weekly (Jan 12)- Wuxi Biologics, Astellas, Otsuka, Samsung Biologics, Pharmaessentia

APAC healthcare companies got approvals for new products as well as clinical trials. The companies continued with acquisitions and collaborations...

Tina Banerjee

CX Daily: Why More Chinese Companies Are Getting Sued by Aggrieved Investors

Lawsuits / In Depth: Why more Chinese companies are getting sued by aggrieved investors Class-action lawsuits against listed companies are popular...

Caixin Global

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