Latest News
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Pfizer updates papers for its $43 billion acquisition of Seagen as the FTC keeps a watch on biopharma M&A deals
Source: Pfizer A month later, Pfizer withdrew its notice for its proposed $43 billion acquisition of cancer medication expert Seagen ...
Sanofi Consumer Healthcare introduces a new site to advance science and address significant self-care issues
Source – Sanofi On June 15, a new Open Innovation Portal was made available by Sanofi’s Consumer Healthcare Business Unit, ...
To speed up patient access to Biosimilar medications, Sandoz announces the Act4 Biosimilars Action Plan
Source – Novartis On June 15, a global plan to improve patient access to biologic medicines was launched, according to ...
Another Stelara patent settlement was reached by J&J, this time with Alvotech and Teva
Source – Johnson & Johnson By early 2025, a new settlement may allow for the entry of a second biosimilar ...
In Germany, a COVID-19 vaccine damage claim will be defended by BioNTech
Source- BioNTech The COVID-19 vaccine partner of Pfizer, BioNTech, is going to court in its native Germany to defend itself ...
Healthware Group and Digital Therapeutics Alliance launch website and DTx policy report
Source – Healthware Group On 9 June 2023, the European DTx Policy Coalition was established by Healthware Group and the ...
Astellas Faces Setback in the US Patent Trial for Myrbetriq
Source – Astellas An important patent that Astellas has on the urinary incontinence medicine Myrbetriq has been declared invalid by ...
Huma Received FDA Class II clearance for the SaMD platform
Source – HUMA With the FDA’s Class II clearance of its Software as a Medical Device (SaMD) disease management platform, ...
Almirall plans to expand its pipeline with €200 million in capital
Source – Almirall Almirall has completed a €200 million share capital issue, some of which will be used to finalize ...
Merck wins patent case for BRIDION in US District Court
Source- Merck On June 13, 2023 the US District Court for the District of New Jersey found in favor of ...
FDA authorizes the first medication for functional constipation in children
Source- FDA Pediatric patients aged 6 to 17 may use Linzess (linaclotide) pills to treat functional constipation. The first therapy ...
In order to provide access to cervical cancer screening tools in low- and lower-middle income countries, Roche received WHO prequalification for the Cobas HPV test
Source – Roche On June 13, 2023, the World Health Organisation (WHO) prequalified the Cobas Human Papillomavirus (HPV) test for ...
Futura receives FDA approval for OTC treatment for erectile dysfunction
Source- Futura Medical The first business in the US to provide a topical erectile dysfunction medication to the market without ...
In the US, patients with advanced HR-positive breast cancer are given priority review for the combination of capivasertib and Faslodex
Source- Astrazeneca The US Food and Drug Administration (FDA) has accepted and granted Priority Review to AstraZeneca’s New Drug Application ...
For the treatment of people with refractory generalized myasthenia gravis, Soliris has received approval in China
Source- Astrazeneca For the treatment of adult patients with refractory generalized myasthenia gravis (gMG) and anti-acetylcholine receptor (AChR) antibody positivity, ...
Novartis has agreed to purchase Chinook Therapeutics for USD 3.2 billion upfront (USD 40 per share), strengthening its new medicines strategy and renal portfolio in the process
On 12 June 2023 Novartis revealed that it has reached a deal to purchase Chinook Therapeutics, a clinical-stage biopharmaceutical business ...
SAR’579/IPH6101 Granted FDA Fast Track Designation for Hematological Malignancies
Source: Innate Pharma On June 6, 2023, the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ...
FDA Advisory Committee Unanimously Recommends Nirsevimab for Preventing RSV Lower Respiratory Tract Disease in Infants
Source: AstraZeneca The FDA’s Antimicrobial Drugs Advisory Committee (AMDAC) has voted unanimously, with a 21 to 0 decision, affirming the ...
Novartis Survey Challenges Perception of CML as a Resolved Disease, Revealing Ongoing Impact and Need for Attention
Source: Novartis On June 9, 2023, Novartis reveals CML (chronic myeloid leukemia) SUN Results at 2023 European Hematology Association (EHA) ...
European Commission Approves COSENTYX as First and Only IL-17A Inhibitor for Hidradenitis Suppurativa
Source: Novartis On June 1, 2023, Novartis announced that the European Commission (EC) has granted approval for the use of ...
FDA Advisory Committee Vote Validates LEQEMBI Alzheimer’s Treatment
Source: Eisai On June 9, 2023, the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) of the US Food ...
AstraZeneca Enters $2 Billion Deal with Quell for Treg Cell Therapy
British start-up Quell Therapeutics has secured a collaboration with AstraZeneca focused on cell therapies for autoimmune diseases, with an upfront ...
FDA Sets December Deadline for Vertex and CRISPR’s Sickle Cell Therapy
The US Food and Drug Administration (FDA) has initiated a priority review of exagamglogene autotemcel (exa-cel), a therapy developed by ...
Samsung Biologics Secures $411 Million Long-Term Deal with Pfizer for Biosimilar Production
South Korea’s Samsung Biologics has recently entered into another significant manufacturing agreement, this time with Pfizer, worth $411 million. The ...
Sandoz Aims for Success in Biosimilars, Forecasts $3 Billion in Sales from Pipeline Products in Next 5 Years
Sandoz, the generics and biosimilars division of Novartis, is set to become an independent company and is determined to reverse ...
CDC Raises Concerns about Deadly Bacteria with High Fatality Rate Endemic to US Gulf Coast
A highly dangerous bacterium, known as Burkholderia pseudomallei, has recently been declared endemic to the US Gulf Coast by the ...
Eisai has requested to approve Leqembi, its therapy for Alzheimer’s disease, in South Korea
This filing comes just before an FDA advisory committee meeting, which has raised expectations of the drug receiving full approval ...
FDA accepts Merck’s application for Keytruda plus chemo in liver cancer
The FDA has granted acceptance to Merck’s application for the popular drug Keytruda, in combination with standard-of-care chemotherapy (gemcitabine plus ...
GSK Secures First Approval for RSV Vaccine in EU
The European Commission has given the green light for GSK’s Arexvy to be used in older adults aged 60 or ...
Johnson & Johnson (J&J) Moves Closer to FDA Approval for CAR-T Therapy
The company has filed for approval to use Carvykti earlier in the treatment pathway, including for patients experiencing their first ...