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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

Pfizer updates papers for its $43 billion acquisition of Seagen as the FTC keeps a watch on biopharma M&A deals

SG Tylor

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

Sanofi Consumer Healthcare introduces a new site to advance science and address significant self-care issues

SG Tylor

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

To speed up patient access to Biosimilar medications, Sandoz announces the Act4 Biosimilars Action Plan

SG Tylor

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 Johnson & Johnson, this time with Alvotech and Teva

Another Stelara patent settlement was reached by J&J, this time with Alvotech and Teva

SG Tylor

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

In Germany, a COVID-19 vaccine damage claim will be defended by BioNTech

SG Tylor

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

Healthware Group and Digital Therapeutics Alliance launch website and DTx policy report

SG Tylor

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

Astellas Faces Setback in the US Patent Trial for Myrbetriq

SG Tylor

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

Huma Received FDA Class II clearance for the SaMD platform

SG Tylor

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

Almirall plans to expand its pipeline with €200 million in capital

SG Tylor

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

Merck wins patent case for BRIDION in US District Court

SG Tylor

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

FDA authorizes the first medication for functional constipation in children

SG Tylor

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

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

SG Tylor

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

Futura receives FDA approval for OTC treatment for erectile dysfunction

SG Tylor

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

In the US, patients with advanced HR-positive breast cancer are given priority review for the combination of capivasertib and Faslodex

SG Tylor

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

For the treatment of people with refractory generalized myasthenia gravis, Soliris has received approval in China

SG Tylor

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

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

SG Tylor

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

SAR’579/IPH6101 Granted FDA Fast Track Designation for Hematological Malignancies

SG Tylor

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

FDA Advisory Committee Unanimously Recommends Nirsevimab for Preventing RSV Lower Respiratory Tract Disease in Infants

SG Tylor

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

Novartis Survey Challenges Perception of CML as a Resolved Disease, Revealing Ongoing Impact and Need for Attention

SG Tylor

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

European Commission Approves COSENTYX as First and Only IL-17A Inhibitor for Hidradenitis Suppurativa

SG Tylor

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

FDA Advisory Committee Vote Validates LEQEMBI Alzheimer’s Treatment

SG Tylor

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

AstraZeneca Enters $2 Billion Deal with Quell for Treg Cell Therapy

SG Tylor

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

FDA Sets December Deadline for Vertex and CRISPR’s Sickle Cell Therapy

SG Tylor

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

Samsung Biologics Secures $411 Million Long-Term Deal with Pfizer for Biosimilar Production

SG Tylor

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 Aims for Success in Biosimilars, Forecasts $3 Billion in Sales from Pipeline Products in Next 5 Years

SG Tylor

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

CDC Raises Concerns about Deadly Bacteria with High Fatality Rate Endemic to US Gulf Coast

SG Tylor

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

Eisai has requested to approve Leqembi, its therapy for Alzheimer’s disease, in South Korea

SG Tylor

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

FDA accepts Merck’s application for Keytruda plus chemo in liver cancer

SG Tylor

The FDA has granted acceptance to Merck’s application for the popular drug Keytruda, in combination with standard-of-care chemotherapy (gemcitabine plus ...

GSK has achieved a significant milestone by securing the first approval for a vaccine against respiratory syncytial virus (RSV) in the European Union

GSK Secures First Approval for RSV Vaccine in EU

SG Tylor

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) has taken a significant step towards gaining FDA approval for its CAR-T therapy, Carvykti, in the treatment of multiple myeloma

Johnson & Johnson (J&J) Moves Closer to FDA Approval for CAR-T Therapy

SG Tylor

The company has filed for approval to use Carvykti earlier in the treatment pathway, including for patients experiencing their first ...