Bayer agrees to pay $40m to resolve claims on three drugs

5 September | LEGAL

Bayer has agreed to make a payment of $40m for settling claims over the alleged violations of the False Claims Act linked to three drugs, Trasylol, Avelox and Baycol, the US Department of Justice said in a press statement.  The settlement comes after a former Bayer employee, Laurie Simpson, filed two ‘whistleblower’ lawsuits against the company.  

These litigations were filed under the qui tam or whistleblower provisions of the False Claims Act, which facilitate private citizens to file lawsuits against fake claims on behalf of the government. Simpson alleged in a lawsuit filed in the District of New Jersey that Bayer paid kickbacks to physicians and hospitals to prompt them to use Trasylol and Avelox.

10 August | REGULATORY

FDA grants Fast-Track status for Relmada’s major depressive disorder therapy

The US Food and Drug Administration (FDA) has granted Fast-Track designation to Relmada Therapeutics’ REL-1017 as a single agent to treat major depressive disorder (MDD). An NMDA receptor (NMDAR) channel blocker, REL-1017 acts on hyperactive channels while preserving physiological glutamatergic neurotransmission.  A registrational Phase III trial, Reliance III, is analysing REL-1017 as a single agent. In addition, Reliance I and Reliance II are two Phase III sister placebo-controlled, two-arm trials analysing REL-1017 as a potential adjunctive MDD therapy.

18 August | DEALS

Atomwise and Sanofi partner for drug discovery using AI

Atomwise and Sanofi have entered a strategic and exclusive research partnership to use the former’s artificial intelligence (AI)-driven AtomNet platform to discover and research up to five drug targets computationally. Under the multi-target collaboration, Atomwise will receive an upfront payment of $20m from Sanofi for identifying, synthesising and progressing lead compounds for up to five targets. These targets will be exclusive to Sanofi. Atomwise is also eligible to receive additional research, development and sales-based milestone payments totalling to over $1bn.

29 August | Legal

Moderna files lawsuits against Pfizer and BioNTech over mRNA technology

Moderna has filed patent infringement lawsuits in the US District Court for the District of Massachusetts and the Regional Court of Düsseldorf in Germany against Pfizer and BioNTech over messenger ribonucleic acid (mRNA) technology. Pfizer and BioNTech’s Covid-19 vaccine, Comirnaty, is said to have infringed patents filed by Moderna between 2010 and 2016 for its mRNA technology. Moderna alleged that Pfizer and BioNTech used this technology without seeking the company’s permission to create Comirnaty. The company will not seek the removal of Pfizer and BioNTech’s Covid-19 vaccine, Comirnaty, from the market.

9 September | DEALS

Gatehouse Bio and AstraZeneca to develop RNA therapeutics for heart failure

US-based biotech company Gatehouse Bio is extending its collaboration with AstraZeneca for developing RNA therapeutics to treat heart failure with preserved ejection fraction (HFpEF). Initially, the companies partnered to identify new targets for respiratory and cardiovascular diseases using Gatehouse Bio’s artificial intelligence (AI)-powered platform in December 2019. Gatehouse Bio is engaged in developing small RNA-based therapeutics using AI technology. The partnership is expected to expedite the development of a range of new therapeutics using the small non-coding genome area.

17 August | R&D

Merck and Orna partner for RNA technology-based vaccines and therapies

Merck (MSD outside North America) has entered a partnership agreement with Orna Therapeutics for discovering, developing and marketing various programmes based on next-generation RNA technology. These programmes will include therapies and vaccines in infectious disease and oncology areas. By self-circularisation, Orna’s oRNA technology makes circular ribonucleic acids (oRNAs) from linear RNAs. oRNA molecules have been demonstrated to possess increased stability in vivo compared to linear mRNA and can potentially create more quantities of therapeutic proteins within the body.

In Brief

PathAI expands AI-driven partnership with BMS

PathAI has expanded a multi-year partnership agreement with Bristol Myers Squibb (BMS) to leverage artificial intelligence (AI)-powered pathology in translational research and clinical trials. In the initial stage, the deal will focus on key translational research in oncology, fibrosis and immunology areas to advance the work into clinical development.

Merck KGaA and Guardant expand partnership to develop cancer therapies

Guardant Health has extended a partnership with Merck KGaA, Darmstadt, Germany, to aid in expediting precision oncology therapeutics development. The companies will use the GuardantINFORM real-world evidence (RWE) platform to boost works for developing Merck’s precision cancer pipeline.

FDA accepts Sanofi’s haemophilia A treatment BLA for priority review

The US FDA has accepted Sanofi’s efanesoctocog alfa (BIVV001) Biologics License Application (BLA), intended to treat haemophilia A, for priority review. A decision from the regulatory agency on approval for the therapy is anticipated on 28 February next year.

Tetra and Cellvera partner to develop oral Covid-19 treatment

Tetra Bio-Pharma and Cellvera have entered an agreement to jointly develop ARDS-003 as an oral combination therapeutic candidate with 400mg Qifenda (Favipiravir) for Covid-19. ARDS-003 contains onternabez, a selective full agonist of the type 2 cannabinoid receptor.

26 August | DEALS

Novartis announces plans to spin off Sandoz business

Novartis has announced plans to completely spin off its generics and biosimilars division, Sandoz, to create a new publicly traded standalone firm. The latest development is intended to increase shareholder value by establishing a top European generics firm and a leader in biosimilars internationally. Following the proposed spin-off, Sandoz will establish headquarters in Switzerland. 

2 September | DEALS

Novo Nordisk agrees to acquire biopharma firm Forma for $1.1bn

Novo Nordisk has signed a definitive agreement for the acquisition of clinical-stage biopharmaceutical firm Forma Therapeutics for $20 for each share in cash or a total equity price of $1.1bn. Forma focuses on researching, developing and marketing new therapies for patients with sickle cell disease (SCD), rare hematologic diseases and cancers. 

In brief

PathAI expands AI-driven partnership with BMS

PathAI has expanded a multi-year partnership agreement with Bristol Myers Squibb (BMS) to leverage artificial intelligence (AI)-powered pathology in translational research and clinical trials. In the initial stage, the deal will focus on key translational research in oncology, fibrosis and immunology areas to advance the work into clinical development.

Merck KGaA and Guardant expand partnership to develop cancer therapies

Guardant Health has extended a partnership with Merck KGaA, Darmstadt, Germany, to aid in expediting precision oncology therapeutics development. The companies will use the GuardantINFORM real-world evidence (RWE) platform to boost works for developing Merck’s precision cancer pipeline.

FDA accepts Sanofi’s haemophilia A treatment BLA for priority review

The US FDA has accepted Sanofi’s efanesoctocog alfa (BIVV001) Biologics License Application (BLA), intended to treat haemophilia A, for priority review. A decision from the regulatory agency on approval for the therapy is anticipated on 28 February next year.

Tetra and Cellvera partner to develop oral Covid-19 treatment

Tetra Bio-Pharma and Cellvera have entered an agreement to jointly develop ARDS-003 as an oral combination therapeutic candidate with 400mg Qifenda (Favipiravir) for Covid-19. ARDS-003 contains onternabez, a selective full agonist of the type 2 cannabinoid receptor.