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Endpoints News, Lawrence, KS (2024)

05/20/2024

Exclusive: Members of Congress buy and sell stocks that would gain from bill banning China biotech companies

At least seven members of Congress since 2023 have bought and sold stocks of life science companies that would gain from legislation to ban several key Chinese biotech suppliers and contractors, according to financial disclosures. The Biosecure Act, which advanced in the House last week, would force...

05/14/2024

Senior Biopharma Correspondent Andrew Dunn sat down (virtually) with biotech's Renaissance man, Siddhartha Mukherjee, in the latest Endpoints Slack Interview. They talked about AI, Mukherjee's slew of ambitious biotech startups, and how he got into writing epic, Pulitzer-winning tomes on medicine and science.

Siddhartha Mukherjee is something of a biotech Renaissance man. First and foremost, he sees himself as an oncologist. But that core interest has led him in many directions, including running a research lab at Columbia University, co-founding a growing list of biotech startups, and writing books on s...

05/13/2024

Novo Nordisk said Monday that its investigational treatment met both primary endpoints in an open-label Phase 3a study in patients with hemophilia A, meaning patients had fewer bleeding episodes.

Novo Nordisk said Monday that its investigational treatment met both primary endpoints in an open-label Phase 3a study in patients with hemophilia A, meaning patients had fewer bleeding episodes. Following the topline FRONTIER 2 data disclosure via a press release, the Danish drugmaker's shares $NVO...

05/09/2024

Ten out of 11 children who were born deaf can now hear after receiving a gene therapy from a Shanghai biotech, according to new results shared Thursday.

BALTIMORE — Ten out of 11 children who were born deaf can now hear after receiving a gene therapy from a Shanghai biotech, according to new results shared Thursday. The children who recovered their hearing are also showing improvements in their ability to speak. Some are saying the words “mama.....

05/08/2024

For the first time in April, biosimilars started to gain a larger share of the Humira market. Up until that point, the market felt unimpeachable, with AbbVie’s Humira retaining 96% of the share by February. That changed when Humira came off the formulary of CVS Health’s pharmacy benefit manager Caremark.

(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) For the first time in April, biosimilars started to gain a larger share of the Humira market. Up until that point, the market felt unimpeachable, with AbbVie's Humira retaining 96% of the

05/07/2024

A Duchenne muscular dystrophy patient died of cardiac arrest on Friday in a Phase 2 trial of Pfizer’s gene therapy, the pharma company confirmed.

A Duchenne muscular dystrophy patient died of cardiac arrest on Friday in a Phase 2 trial of Pfizer’s gene therapy, the pharma company confirmed. The patient received fordadistrogene movaparvovec in early 2023 as part of Pfizer’s DAYLIGHT study enrolling patients 2 and 3 years old. As a result o...

05/06/2024

The Centers for Medicare & Medicaid Services proposed a number of changes to its Medicare negotiation guidance on Friday, some of which would affect how the next round of drug prices is negotiated under the Inflation Reduction Act. On Monday, industry groups PhRMA and BIO raised new concerns about the guidance.

The Centers for Medicare & Medicaid Services proposed a number of changes to its Medicare negotiation guidance on Friday, some of which would affect how the next round of drug prices is negotiated under the Inflation Reduction Act. On Monday, industry groups PhRMA and BIO raised new concerns about t...

05/03/2024

AbbVie is investing around €150 million ($161 million) into an R&D site at its Rhineland-Palatinate location in Germany which it expects to complete in 2027, the company announced this week.

AbbVie is investing around €150 million ($161 million) into an R&D site at its Rhineland-Palatinate location in Germany which it expects to complete in 2027, the company announced this week. At a site that employs more than 2,000 already, the new building will house more than 300 employees in onco...

05/02/2024

Despite the pharmaceutical industry’s heavy criticism of the Inflation Reduction Act, Johnson & Johnson, Pfizer and Bristol Myers Squibb recently downplayed the legislation’s overall impact on business in first-quarter earnings calls.

Despite the pharmaceutical industry’s heavy criticism of the Inflation Reduction Act, Johnson & Johnson, Pfizer and Bristol Myers Squibb recently downplayed the legislation’s overall impact on business in first-quarter earnings calls. All three companies voiced early opposition to the IRA, liken...

04/26/2024

Sen. Bernie Sanders (I-VT) is calling on global pharmaceutical leaders to get behind proposals laid out in a World Health Organization-led global pandemic preparedness agreement that’s nearing completion.

Sen. Bernie Sanders (I-VT) is calling on global pharmaceutical leaders to get behind proposals laid out in a World Health Organization-led global pandemic preparedness agreement that's nearing completion. On Thursday, Sanders wrote to the International Federation of Pharmaceutical Manufacturers and....

04/25/2024

GSK says it is owed a portion of Pfizer and BioNTech’s Covid-19 vaccine sales in the latest patent suit filed against the Comirnaty partners.

GSK says it is owed a portion of Pfizer and BioNTech’s Covid-19 vaccine sales in the latest patent suit filed against the Comirnaty partners. In a lawsuit filed in federal court in Delaware Thursday, the UK pharma claimed Pfizer and BioNTech benefited from mRNA research conducted more than a decad...

04/24/2024

Roche on Wednesday morning said it has “minor exposure” from the Biosecure Act, adding that it is making strides in China’s pharma and diagnostics markets.

Roche on Wednesday morning said it has “minor exposure” from the Biosecure Act, adding that it is making strides in China’s pharma and diagnostics markets. “We’ve really worked on diversifying our supply chain and this is helping us now, so that we have multiple partners to work with acros...

04/23/2024

The FDA granted accelerated approval to Day One Biopharmaceuticals’ pediatric brain tumor treatment.

The FDA granted accelerated approval to Day One Biopharmaceuticals' pediatric brain tumor treatment. The regulator on Tuesday approved tovorafenib, taking place more than five years after Day One was founded with a goal to bring targeted therapies to children, a population that the drug industry has...

04/22/2024

When Regeneron announced a $500 million corporate venture capital fund last week, it was the first time in years that a storied large pharma had done so. The company said it’s investing $100 million a year for five years.

When Regeneron announced a $500 million corporate venture capital fund last week, it was the first time in years that a storied large pharma had done so. The company said it’s investing $100 million a year for five years. “Our goal is to cultivate an ecosystem where the next generation

04/17/2024

A settlement between Eli Lilly and insulin users has collapsed after a federal judge’s ruling that denied class certification for the lawsuit.

A settlement between Eli Lilly and insulin users has collapsed after a federal judge's ruling that denied class certification for the lawsuit. The original settlement stemmed from a 2017 lawsuit in which patients sued the three biggest insulin manufacturers — Eli Lilly, Novo Nordisk and Sanofi —...

04/16/2024

AbbVie is betting more than $1.9 billion on a French biotech’s long-acting injectable technology.

AbbVie is betting more than $1.9 billion on a French biotech’s long-acting injectable technology. The deal gives Medincell $35 million upfront and up to $1.9 billion in milestones for the development of up to six therapeutic long-acting products. Medincell said on Tuesday the work will span “mul...

04/15/2024

As part of efforts to level the playing field between biologics and biosimilars, the FDA is calling on Congress to remove the interchangeability designation for biosimilars, claiming that the two-tier system is only causing confusion.

As part of efforts to level the playing field between biologics and biosimilars, the FDA is calling on Congress to remove the interchangeability designation for biosimilars, claiming that the two-tier system is only causing confusion. When it was established in 2009, the interchangeability designati...

04/12/2024

A new oncology drug endpoint, based on what’s known as minimal residual disease, gained the backing of FDA advisors, potentially opening the door to new trial designs for blood cancer drugs.

A new oncology drug endpoint, based on what’s known as minimal residual disease, gained the backing of FDA advisors, potentially opening the door to new trial designs for blood cancer drugs. An FDA advisory committee voted unanimously on Friday that evidence supports a new intermediate endpoint fo...

04/11/2024

Eli Lilly suffered another loss this week in its legal campaign against compounded versions of its popular diabetes and weight loss drug tirzepatide.

Eli Lilly suffered another loss this week in its legal campaign against compounded versions of its popular diabetes and weight loss drug tirzepatide. A Florida federal judge tossed Lilly’s lawsuit against a Miami compounding pharmacy on Wednesday, ruling that Lilly can’t “use state law as a ba...

04/10/2024

Members of the European Parliament on Wednesday voted overwhelmingly in favor of the first pharma-related legislative overhaul in about two decades. If ultimately agreed to by the European Council, the legislative package will pave the way for slightly shorter regulatory data protection periods and new rewards to entice further investment.

Members of the European Parliament on Wednesday voted overwhelmingly in favor of the first pharma-related legislative overhaul in about two decades. If ultimately agreed to by the European Council, the legislative package will pave the way for slightly shorter regulatory data protection periods and....

04/09/2024

Sanofi is parting ways with the natural killer cell company Kiadis, three and a half years after buying it for $357 million.

Sanofi is parting ways with the natural killer cell company Kiadis, three and a half years after buying it for $357 million. The move was quietly announced via an April 8 update to a clinical trial for SAR445419, an off-the-shelf natural killer cell therapy in development for relapsed/refractory acu...

04/05/2024

In 2022, about nine months before Novo Holdings first reached out to Catalent about a potential deal, the contract manufacturer was in talks with another company with which it had an “existing commercial relationship,” according to a securities filing with background on the $16.5 billion transaction.

In 2022, about nine months before Novo Holdings first reached out to Catalent about a potential deal, the contract manufacturer was in talks with another company with which it had an

04/04/2024

Novartis said Thursday in a brief, five-sentence press release that it plans to file for an expanded label for its prostate cancer treatment Pluvicto in the second half of this year.

Novartis said Thursday in a brief, five-sentence press release that it plans to file for an expanded label for its prostate cancer treatment Pluvicto in the second half of this year. The expanded label could potentially make the radiopharmaceutical available to two to three times the number of patie...

04/03/2024

Genmab is an unusual company in pharma. In 25 years, it has 44 INDs — 20 of those are still in clinical development — and eight marketed medicines. Until Wednesday’s $1.8 billion deal for antibody-drug conjugate maker ProfoundBio, it had never done a takeover.

Genmab is an unusual company in pharma. In 25 years, it has 44 INDs — 20 of those are still in clinical development — and eight marketed medicines. Until Wednesday's $1.8 billion deal for antibody-drug conjugate maker ProfoundBio, it had never done a takeover. But it's not the drugmaker’s firs...

04/02/2024

CMS wants further discussions with pharma companies that are participating in IRA price negotiations, HHS announced on Tuesday.

CMS wants further discussions with pharma companies that are participating in IRA price negotiations, HHS announced on Tuesday. The agency said it has responded to counteroffers proposed by all of the participating manufacturers, but declined to comment further. According to CMS’ guidelines, the a...

04/01/2024

Lawmakers in Congress are alleging that the Chinese genomics giant BGI set up subsidiaries in the US to try and avoid regulatory and political scrutiny, and in a letter pushed for those subsidiaries to be added to a Pentagon list of firms that allegedly work with the Chinese military.

Lawmakers in Congress are alleging that the Chinese genomics giant BGI set up subsidiaries in the US to try and avoid regulatory and political scrutiny, and in a letter pushed for those subsidiaries to be added to a Pentagon list of firms that allegedly work with the Chinese military. The

03/28/2024

WuXi AppTec reportedly transferred a US client’s intellectual property to Chinese authorities, American intelligence officials told Congress in February.

WuXi AppTec reportedly transferred a US client’s intellectual property to Chinese authorities, American intelligence officials told Congress in February. According to a Reuters report published Thursday morning, officials from multiple US agencies briefed senators in late February about the transf...

03/27/2024

What exactly will define the next decade of drug discovery? New modalities plus AI are shaking up old paradigms — find out the latest from top minds in research, industry and more. Sign up for our free virtual event today.

An explosion of new technologies is revolutionizing how biopharma researchers identify new targets and new drugs. But where is the line between hope and hype? Join us for an in-depth look at the people and tech at the cutting edge of research — how do they see the future? Find out what exactly wil...

03/26/2024

Supreme Court justices appeared uncertain on Tuesday that doctors and anti-abortion groups have standing to challenge the FDA’s current label for the commonly used abortion pill mifepristone.

WASHINGTON, DC – Supreme Court justices appeared uncertain on Tuesday that doctors and anti-abortion groups have standing to challenge the FDA’s current label for the commonly used abortion pill mifepristone. The Court is tasked with deciding whether to uphold a Fifth Circuit decision reversing ...

03/25/2024

In Congress, influential lawmakers see a Chinese government threat to the US biotech sector. In the competitive world of biopharma manufacturing, companies see an opportunity.

In Congress, influential lawmakers see a Chinese government threat to the US biotech sector. In the competitive world of biopharma manufacturing, companies see an opportunity. Over the past several months, as WuXi AppTec, WuXi Biologics and BGI Group have been targeted by lawmakers with proposed leg...