Clinical Research Informer

Madrigal wins FDA approval of first drug for MASH

Bio Pharma Dive

MARCH 14, 2024

Rezdiffra’s clearance is a turning point in the fight against the liver disease. But its sales potential is unclear, and competition could emerge from popular weight loss drugs.

FDA Approval

FDA Approval Drugs Sales

German biotech Tubulis cashes in on ADC ‘momentum’ with €128M financing

Bio Pharma Dive

MARCH 14, 2024

The funding for the startup, which partnered with Bristol Myers Squibb last year, adds to a surge of recent investments in developers of antibody-drug conjugates.

Antibody

Antibody Development Drugs

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

Frontier gets $80M, Galapagos’ backing to make a better KRAS drug

Bio Pharma Dive

FEBRUARY 22, 2024

The startup’s Series C round will support a clinical-stage drug the company thinks could address some of the weaknesses of other KRAS-targeting medicines.

Drugs

Drugs Medicine

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

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

Women’s health companies, battling under-investment in research, see growing opportunity

Bio Pharma Dive

JANUARY 16, 2024

While investment remains lower than in other areas of drug R&D, executives and VCs speak of growing momentum for a field that’s been overlooked in the past.

Research

Research Drugs

Life sciences leaders invest in process mining to accelerate digital transformation

Bio Pharma Dive

DECEMBER 11, 2023

Research from Everest Group shows how life sciences leaders are investing in process mining to speed time-to-market, improve regulatory compliance and drive innovation.

Life Science

Life Science Compliance Marketing Research

Profitable growth is on the horizon

Bio Pharma Dive

DECEMBER 11, 2023

A return to profitable growth is on the horizon—organizations that take advantage of the following key trends can thrive in 2024 and beyond.

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

Bluebird gene therapy, now approved for sickle cell, shows durable benefit in study update

Bio Pharma Dive

DECEMBER 9, 2023

Follow-up data continue to show Lyfgenia can address the pain crises people with sickle cell experience, although Bluebird’s therapy will be compared to Vertex and CRISPR Therapeutics’ Casgevy, which was also approved Friday.

Gene Therapy

Gene Therapy Gene

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

Data infrastructure excellence changing the shape of biopharma manufacturing

Bio Pharma Dive

NOVEMBER 20, 2023

Biopharma companies capture data across a variety of different fronts and, so this data must be managed effectively in order to unlock business efficiencies and drive improvements.

Manufacturing

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

‘We’re in the 1999 of the internet era’: a16z’s Julie Yoo on fintech’s potential and the digital health market

Bio Pharma Dive

AUGUST 31, 2023

Yoo, who leads health tech investment at venture capital firm Andreessen Horowitz, outlined her fintech investment thesis and why the healthcare industry is at an inflection point.

Marketing

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

Superluminal draws RA Capital, Nvidia as investors in GPCR drug hunt

Bio Pharma Dive

AUGUST 28, 2023

GPCRs, a ubiquitous family of proteins that are prime drug targets, have drawn the interest of companies like Structure Therapeutics, Septerna and now Superluminal Medicines.

Drugs

Drugs Protein Medicine

Danaher to buy antibody supplier Abcam for $5.7B

Bio Pharma Dive

AUGUST 28, 2023

The acquisition gives Danaher ownership of a producer of research tools, such as antibodies and reagents, that are used in drug discovery experiments.

Antibody

Antibody Reagent Drugs Research

Bayer reports positive early data for Parkinson’s cell therapy

Bio Pharma Dive

AUGUST 28, 2023

The treatment, developed by a biotech Bayer acquired in 2019, appeared safe in a small trial and showed signs of an effect on disease progression.

Trials

Trials Development

FTC pulls back on legal challenge to Amgen’s $28B bid for Horizon

Bio Pharma Dive

AUGUST 28, 2023

Urged by a judge, the antitrust regulator said it wants to start discussions “regarding the proper resolution of this matter” — a potential prelude to a settlement.

Regulation

Artificial intelligence: The prime mover in drug discovery

Bio Pharma Dive

AUGUST 28, 2023

With its ability to process vast amounts of data and identify patterns, AI can significantly reduce the time and cost involved in developing new drugs.

Drugs

Drugs Development

The intelligent content ecosystem is here. Is your organization ready?

Bio Pharma Dive

AUGUST 28, 2023

Is pharma up to the challenge of delivering the personalized and contextual experiences doctors have come to expect? Too often, the answer is no.

Doctors

Doctors Doctor

Cell therapy startup Turnstone adds to biotech IPO flurry with $80M raise

Bio Pharma Dive

JULY 21, 2023

The offering is a financial lifeline for Turnstone and the fourth for the sector this month, the first time that’s happened in nearly a year and a half, according to BioPharma Dive data.

Idorsia warns of up to 500 layoffs as part of cost-cutting initiative

Bio Pharma Dive

JULY 21, 2023

The Swiss drugmaker now joins a lengthy list of biotechs that, amid a drawn-out market downturn, have turned to job cuts and research re-evaluations to save money.

Marketing

Marketing Research

Mirati’s KRAS-blocking cancer drug hits setback in Europe

Bio Pharma Dive

JULY 21, 2023

A key committee for the European Medicines Agency recommended against approval of the targeted therapy. Mirati said it intends to appeal the decision.

Medicine

Medicine Drugs

Bio Pharma Dive

Madrigal wins FDA approval of first drug for MASH

German biotech Tubulis cashes in on ADC ‘momentum’ with €128M financing

Trending Sources

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

Frontier gets $80M, Galapagos’ backing to make a better KRAS drug

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

Brain drug developer Alto Neuroscience prices $129M IPO

Women’s health companies, battling under-investment in research, see growing opportunity

Life sciences leaders invest in process mining to accelerate digital transformation

Profitable growth is on the horizon

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

Bluebird gene therapy, now approved for sickle cell, shows durable benefit in study update

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’

Data infrastructure excellence changing the shape of biopharma manufacturing

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

‘We’re in the 1999 of the internet era’: a16z’s Julie Yoo on fintech’s potential and the digital health market

Medicare names first 10 drugs for price negotiations

Superluminal draws RA Capital, Nvidia as investors in GPCR drug hunt

Danaher to buy antibody supplier Abcam for $5.7B

Bayer reports positive early data for Parkinson’s cell therapy

FTC pulls back on legal challenge to Amgen’s $28B bid for Horizon

Artificial intelligence: The prime mover in drug discovery

The intelligent content ecosystem is here. Is your organization ready?

Cell therapy startup Turnstone adds to biotech IPO flurry with $80M raise

Idorsia warns of up to 500 layoffs as part of cost-cutting initiative

Mirati’s KRAS-blocking cancer drug hits setback in Europe

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