Clinical Research Informer

Roche autoimmune disease drug disappoints in closely watched trial

Bio Pharma Dive

MARCH 21, 2024

Though the medicine hit its goal in a Phase 3 study in myasthenia gravis, the results fell short of expectations in a boost to rival drug developers like Argenx and AstraZeneca.

Drugs

Drugs Trials Medicine Development

Bayer streamlines pharma leadership team amid company shakeup

Bio Pharma Dive

MARCH 21, 2024

The executive team will reportedly shrink from 14 to eight in the latest step in new CEO Bill Anderson’s plan to slash management and reduce “bureaucracy” at the healthcare conglomerate.

Thermo Fisher, Bayer partner to develop companion diagnostics

Bio Pharma Dive

MARCH 21, 2024

The companies aim to identify potential patients for Bayer’s precision cancer therapies and increase access to the treatments.

Development

Mirador debuts with $400M, picking up where immune drugmaker Prometheus left off

Bio Pharma Dive

MARCH 21, 2024

The financing for the startup, which is led by former executives of a biotech Merck recently bought for nearly $11 billion, is the sector’s largest for a privately held company this year.

Give HCPs a proactive way to reach your field team: Add inbound

Bio Pharma Dive

MARCH 18, 2024

HCPs today want inbound channels for help when they need it. See how you can meet their preferences.

The digital divide: Balancing automation and human interaction regardless of the patient support program model

Bio Pharma Dive

MARCH 18, 2024

Balancing automated patient support with human touch is key in healthcare. Hybrid models offer a pragmatic path forward, prioritizing patient-centricity.

Allogene taps Arbor in pursuit of ‘off-the-shelf’ CAR-T therapies for autoimmune disease

Bio Pharma Dive

MARCH 12, 2024

Allogene’s partnership with Arbor is designed to help the company stand out in what’s quickly become one of the industry’s hottest areas of drug research.

Drugs

Drugs Research

Acadia drug fails schizophrenia trial, setting back company’s expansion plans

Bio Pharma Dive

MARCH 12, 2024

The setback shuts out Acadia’s top medicine from a large sales opportunity and heightens the biotech’s dependence on a pipeline filled with risky drug prospects.

Drugs

Drugs Sales Trials Medicine

After surprise trial failure, ALS doctors brace for one less treatment option

Bio Pharma Dive

MARCH 12, 2024

Physicians are preparing for tough conversations with patients on Amylyx Pharmaceuticals’ drug, Relyvrio, while holding out hope it still may help some with the disease.

Doctors

Doctors Doctor Trials Drugs

Roche, following setbacks, turns to its next Alzheimer’s drug

Bio Pharma Dive

MARCH 11, 2024

Roche said its experimental Alzheimer’s disease drug trontinemab showed it might be able to clear brain plaques faster than other medicines.

Drugs

Drugs Medicine

Boehringer, Sosei Heptares team up in schizophrenia drug deal

Bio Pharma Dive

MARCH 11, 2024

Sosei Heptares could receive more than 700 million euros in a deal to develop medicines aimed at the protein GPR52, an emerging drug target in multiple neurological diseases.

Drugs

Drugs Protein Medicine Development

Amylyx CEOs look for a path forward following major setback

Bio Pharma Dive

MARCH 11, 2024

Justin Klee and Joshua Cohen spoke to BioPharma Dive about the next steps for their company, which is considering pulling its only product from market after the drug failed a confirmatory study in ALS.

Production

Production Marketing Drugs

Biotech stock fundings headed for best quarter in 3 years, Jefferies says

Bio Pharma Dive

MARCH 11, 2024

Publicly traded companies raised nearly $10 billion in follow-on stock offerings in January and February, a financing surge that’s driving a “sector recovery,” the investment bank said.

J&J’s growing rare disease focus brings a potential multi-use treatment to the table

Bio Pharma Dive

MARCH 11, 2024

The head of J&J’s autoantibody programs believes nipocalimab is unique among potential rare disease drugs because it can harness a common thread among them.

Drugs

J&J secures EMA backing for earlier CAR-T use in multiple myeloma

Bio Pharma Dive

FEBRUARY 23, 2024

European drug regulators recommended clearing J&J and Legend Biotech's Carvykti for use as early as after first relapse, potentially giving the therapy an advantage over Bristol Myers’ Abecma.

Regulation

Regulation Drugs

NEJM paper fills in details on ‘remarkable’ CAR-T result in autoimmune disease

Bio Pharma Dive

FEBRUARY 21, 2024

The full results spotlight cell therapy’s potential to treat lupus and other inflammatory conditions, but also the problems drug developers must solve first.

Development

Development Drugs

Bavarian Nordic terminates cancer vaccine work

Bio Pharma Dive

FEBRUARY 21, 2024

The Danish company scrapped a vaccine in Phase 1 testing and will exit oncology altogether, focusing instead on infectious disease research.

Vaccination

Vaccination Vaccine Research

Vir, in midst of restructuring, loses its chief medical officer

Bio Pharma Dive

FEBRUARY 21, 2024

The departure of Phil Pang, who played a key role in developing Vir’s COVID-19 antibody, comes amid a broader company restructuring.

Antibody

Antibody Development

Behind the new kind of cell therapy that just won FDA approval

Bio Pharma Dive

FEBRUARY 21, 2024

One expert views Amtagvi’s approval as a catalyst for further investment in TIL therapies, akin to how Kymriah’s 2017 clearance buoyed CAR-T treatment.

FDA Approval

United Therapeutics, in unusual step, sues FDA over rival’s drug application

Bio Pharma Dive

FEBRUARY 21, 2024

The biotech alleges that the agency is letting competitor Liquidia sidestep the rules by accepting an amendment to an application that’s involved in a patent dispute.

Drugs

Arch, a prolific biotech creator, is raising $3B for startup investing

Bio Pharma Dive

FEBRUARY 2, 2024

A regulatory filing shows the firm is putting together a new multibillion-dollar fund, roughly two years after raising a similar amount.

Brain drug developer Alto Neuroscience prices $129M IPO

Bio Pharma Dive

FEBRUARY 2, 2024

The California biotech is the third this year to go public, following stock offerings from CG Oncology and Arrivent Biopharma.

Development

Development Drugs

‘No tolerance for failure’: An oral history of the first CRISPR medicine

Bio Pharma Dive

DECEMBER 10, 2023

A new sickle cell disease therapy developed by CRISPR Therapeutics and Vertex Pharmaceuticals is now approved in the U.S. and U.K. This is the story of how it came to be.

Medicine

Medicine Development

Pfizer marks progress for successor sickle cell drug at ASH

Bio Pharma Dive

DECEMBER 10, 2023

While new gene therapies for the blood disease grabbed headlines at ASH, Pfizer presented fresh data for an oral drug meant to build on its marketed therapy Oxbryta.

Gene Therapy

Gene Therapy Drugs Gene Marketing

ASH23: CAR-T for autoimmune disease, real-world questions and sickle cell’s social media mentions

Bio Pharma Dive

DECEMBER 9, 2023

Study results disclosed at the American Society of Hematology meeting Saturday suggested potential for cell therapy in lupus and pointed out drug trial limitations.

Drug Trials

Drug Trials Trials Drugs

Merck to buy private biotech Caraway in neuroscience deal

Bio Pharma Dive

NOVEMBER 21, 2023

In a deal worth up to $610 million, Merck will gain a pipeline of neuroscience and rare disease programs from a startup it previously backed.

Roche’s Genentech partners with Nvidia in AI drug deal

Bio Pharma Dive

NOVEMBER 21, 2023

The partnership is another investment by the biotech subsidiary in artificial intelligence for drug discovery and development, continuing an industry trend.

Drugs

Drugs Development

Quotient emerges from Flagship with plan to explore somatic mutations

Bio Pharma Dive

NOVEMBER 21, 2023

Studying somatic mutations could be “the next wave of opportunity” to develop more precise medicines, said Mike Stratton, one of Quotient’s scientific co-founders.

Medicine

Medicine Development

Biohaven hopes to muscle in on Ozempic with a different type of weight loss drug

Bio Pharma Dive

NOVEMBER 20, 2023

Several biotech companies, Biohaven among them, are trying to develop medicines that could trim the waistline while building lean tissue.

Medicine

Medicine Drugs Development

AstraZeneca creates digital health unit, with big-name partnerships already in place

Bio Pharma Dive

NOVEMBER 20, 2023

Called Evinova, the unit will operate as a separate business within AstraZeneca, which sees digital health solutions as a market primed for growth.

Marketing

Bristol Myers faces FDA delay on cancer cell therapy decision

Bio Pharma Dive

NOVEMBER 20, 2023

The regulator plans to convene an advisory panel to discuss an expanded indication for Abecma, presenting another hurdle for Bristol Myers and partner 2seventy bio.

Regulation

Bayer ends large blood thinner trial for ‘inferior efficacy’

Bio Pharma Dive

NOVEMBER 20, 2023

Company shares fell by one-fifth after study monitors called for halting a planned 18,000-person trial because Bayer’s experimental drug wasn’t working as well as Eliquis.

Trials

Trials Drugs

‘Hope is not a strategy’: Health startups short on cash face consolidation, investors say

Bio Pharma Dive

OCTOBER 11, 2023

Some venture investors are putting more of their money into “inside rounds,” while others are exploring opportunities to combine portfolio companies.

PepGen cleared by FDA to begin study of muscular dystrophy drug

Bio Pharma Dive

OCTOBER 12, 2023

The company expects to deliver first results next year from the early-stage study of people with myotonic dystrophy type 1.

Drugs

Research group says FDA found no misconduct in Pfizer Lyme vaccine trial it helped run

Bio Pharma Dive

OCTOBER 12, 2023

Earlier this year Pfizer removed thousands of participants from a study of its Lyme disease shot over concerns the group, Care Access, wasn't meeting clinical practice standards.

Vaccination

Vaccination Vaccine Trials Research

European Commission orders Illumina to divest Grail

Bio Pharma Dive

OCTOBER 12, 2023

The order includes an undisclosed timeline and potential additional fines. Illumina, which has been anticipating the decision, maintains the commission does not have jurisdiction over the completed merger.

FDA denies expanded approval for Alnylam RNA drug

Bio Pharma Dive

OCTOBER 9, 2023

The agency rejected Alnylam’s application for approval of its medicine patisiran in people with a rare heart condition, setting back the company’s plans.

RNA

RNA Drugs Medicine

GSK partners with Chinese pharma to expand Shingrix sales

Bio Pharma Dive

OCTOBER 9, 2023

The purchase agreement with Chongqing Zhifei Biological Products is part of GSK’s plan to double sales of the shingles vaccine by 2026.

Sales

Sales Vaccination Vaccine Production

Using real-world data to improve patient access to oncology therapies

Bio Pharma Dive

OCTOBER 9, 2023

Oncology manufacturers can improve access by using claims, labs, pathway and policy data to address misalignment.

Manufacturing

Bristol Myers to buy KRAS cancer drug developer Mirati for $4.8B

Bio Pharma Dive

OCTOBER 8, 2023

Mirati shareholders could also receive another $1 billion should an experimental cancer drug the biotech is developing make it to U.S. regulators’ desks.

Development

Development Drugs Regulation

Bristol Myers gets key FDA approval for bone marrow disease drug

Bio Pharma Dive

AUGUST 29, 2023

A broadened clearance for Reblozyl in myelodysplastic syndromes should help Bristol Myers offset the looming loss of revenue from top-selling medicines set to soon lose market exclusivity.

FDA Approval

FDA Approval Medicine Drugs Marketing

Apellis to lay off 25% of staff, trim research in major restructuring

Bio Pharma Dive

AUGUST 29, 2023

The job cuts will affect about 225 employees, making it one of the largest single rounds of layoffs within the biotech sector this year.

Research

Catalent expands board in deal with activist investor Elliott

Bio Pharma Dive

AUGUST 29, 2023

The CDMO is adding four new independent directors to its board, and has set up a committee to review its business and capital allocation priorities.

Medicare names first 10 drugs for price negotiations

Bio Pharma Dive

AUGUST 29, 2023

The list includes the top-selling blood thinners Eliquis and Xarelto, as well as the arthritis drug Enbrel and heart failure medicine Entresto.

Drugs

Drugs Medicine

Bio Pharma Dive

Roche autoimmune disease drug disappoints in closely watched trial

Bayer streamlines pharma leadership team amid company shakeup

Trending Sources

Thermo Fisher, Bayer partner to develop companion diagnostics

Mirador debuts with $400M, picking up where immune drugmaker Prometheus left off

Give HCPs a proactive way to reach your field team: Add inbound

The digital divide: Balancing automation and human interaction regardless of the patient support program model

Allogene taps Arbor in pursuit of ‘off-the-shelf’ CAR-T therapies for autoimmune disease

Acadia drug fails schizophrenia trial, setting back company’s expansion plans

After surprise trial failure, ALS doctors brace for one less treatment option

Roche, following setbacks, turns to its next Alzheimer’s drug

Boehringer, Sosei Heptares team up in schizophrenia drug deal

Amylyx CEOs look for a path forward following major setback

Biotech stock fundings headed for best quarter in 3 years, Jefferies says

J&J’s growing rare disease focus brings a potential multi-use treatment to the table

J&J secures EMA backing for earlier CAR-T use in multiple myeloma

NEJM paper fills in details on ‘remarkable’ CAR-T result in autoimmune disease

Bavarian Nordic terminates cancer vaccine work

Vir, in midst of restructuring, loses its chief medical officer

Behind the new kind of cell therapy that just won FDA approval

United Therapeutics, in unusual step, sues FDA over rival’s drug application

Arch, a prolific biotech creator, is raising $3B for startup investing

Brain drug developer Alto Neuroscience prices $129M IPO

‘No tolerance for failure’: An oral history of the first CRISPR medicine

Pfizer marks progress for successor sickle cell drug at ASH

ASH23: CAR-T for autoimmune disease, real-world questions and sickle cell’s social media mentions

Merck to buy private biotech Caraway in neuroscience deal

Roche’s Genentech partners with Nvidia in AI drug deal

Quotient emerges from Flagship with plan to explore somatic mutations

Biohaven hopes to muscle in on Ozempic with a different type of weight loss drug

AstraZeneca creates digital health unit, with big-name partnerships already in place

Bristol Myers faces FDA delay on cancer cell therapy decision

Bayer ends large blood thinner trial for ‘inferior efficacy’

‘Hope is not a strategy’: Health startups short on cash face consolidation, investors say

PepGen cleared by FDA to begin study of muscular dystrophy drug

Research group says FDA found no misconduct in Pfizer Lyme vaccine trial it helped run

European Commission orders Illumina to divest Grail

FDA denies expanded approval for Alnylam RNA drug

GSK partners with Chinese pharma to expand Shingrix sales

Using real-world data to improve patient access to oncology therapies

Bristol Myers to buy KRAS cancer drug developer Mirati for $4.8B

Bristol Myers gets key FDA approval for bone marrow disease drug

Apellis to lay off 25% of staff, trim research in major restructuring

Catalent expands board in deal with activist investor Elliott

Medicare names first 10 drugs for price negotiations

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