Pharma Rep Focus

Ahead of Alnylam's key heart disease readout, experts say Pfizer rival would be hard to displace

Fierce Pharma

APRIL 22, 2024

As a closely watched readout from Alnylam Pharmaceuticals' Amvuttra in the rare heart disease transthyretin amyloid cardiomyopathy (ATTR-CM) is expected in a few weeks, experts suggested the RNA si | As an all-important readout from Alnylam’s Amvuttra in the rare heart disease ATTR-CM is expected in a few weeks, experts suggested that the RNA silencer may have a hard time challenging Pfizer’s tafamidis franchise despite a last-minute trial design change.

Pharmaceutical

Biogen CEO Viehbacher sees 2023 pay fall to $4M after massive welcome package

Fierce Pharma

APRIL 16, 2024

After getting a fat check worth $30.5 million for joining Biogen as the CEO in late 2022, Chris Viehbacher saw his 2023 pay drop to $4.1 million as the Big Biotech continues to struggle. | After getting a fat check worth $30.5 million for joining Biogen as the CEO in late 2022, Chris Viehbacher saw his 2023 pay drop to just $4.1 million as the Big Biotech continues struggling.

With Vyvgart 'firing' in myasthenia gravis, argenx lays launch plans for next potential autoimmune approval: CEO

Fierce Pharma

APRIL 16, 2024

Despite a pair of clinical misfires in 2023, argenx has stuck by the thesis that its star drug Vyvgart, also known as efgartigimod, could tackle a wide array of autoimmune diseases linked to immuno | Argenx is bolstering its case for Vyvgart’s CIDP potential and preparing for a possible launch later this year—all while the company continues to prove the medication’s worth in its inaugural generalized myasthenia gravis indication.

Another Caplyta trial win moves Intra-Cellular closer to FDA filing in major depressive disorder

Fierce Pharma

APRIL 16, 2024

Intra-Cellular Therapies has unveiled another positive late-stage trial readout for Caplyta, taking another step toward a potential blockbuster label expansion for the depression drug. | Intra-Cellular Therapies has unveiled another positive late-stage trial readout for Caplyta, taking another step toward a potential blockbuster label expansion for the depression drug.

FDA

J&J reports strong sales numbers for Tecvayli, bolstering company's multiple myeloma 'stronghold'

Fierce Pharma

APRIL 16, 2024

For the first time, Johnson & Johnson has reported sales numbers for its novel multiple myeloma treatment Tecvayli and they indicate that the bispecific, which was approved in October 2022, is | For the first time, Johnson & Johnson is reporting sales of its multiple myeloma drug Tecvayli, which is off to a strong launch and contributing to the company's overall strength in treating the disease.

Sales

Eisai, Biogen's injectable Leqembi delayed as FDA asks for more data

Fierce Pharma

APRIL 1, 2024

What analysts viewed as a potential “inflection point” for Eisai and Biogen’s slow-footed Leqembi is facing a delay with the FDA. | What analysts viewed as a potential “inflection point” for Eisai and Biogen’s slow-footed Leqembi is facing a delay with the FDA.

FDA

Teva snares up to $150M in Abingworth funding to propel late-stage asthma rescue inhaler

Fierce Pharma

APRIL 1, 2024

Shortly after Gilead Sciences teamed up with Carlyle’s Abingworth to fuel further research on its antibody-drug conjugate Trodelvy, Teva is following a similar pathway with an asthma resc | Shortly after Gilead Sciences teamed up with Carlyle’s Abingworth to fuel further research on its antibody-drug conjugate Trodelvy, Teva is following a similar pathway for an asthma rescue inhaler.

AstraZeneca's rare disease add-on therapy Voydeya scores FDA nod

Fierce Pharma

APRIL 1, 2024

With AstraZeneca’s dominance in the rare blood disease paroxysmal nocturnal hemoglobinuria (PNH) threatened by the recent approval of the first pill on the market for the condition, Novartis’ Fabha | With AstraZeneca’s dominance in the rare blood disease paroxysmal nocturnal hemoglobinuria (PNH) threatened by the recent approval of the first pill on the market for the condition, Novartis’ Fabhalta, AstraZeneca has answered in the United States for its add-on oral treatment in the indication.

FDA

FDA Marketing

Aurisco Pharmaceutical Launches State-of-the-Art Manufacturing Facility for GLP-1 Peptides

Fierce Pharma

MARCH 28, 2024

[Yangzhou, China - March 26, 2024] - Aurisco Pharmaceutical, a leading global pharmaceutical company, is excited to announce the completion of its investment in cGMP peptide manufacturing capacity | Aurisco Pharmaceutical Launches State-of-the-Art Manufacturing Facility for GLP-1 Peptides

Manufacturing

Manufacturing Pharmaceutical Leads

Patented AI Platform Identifies Promising Early-Stage BioPharma Assets and Companies

Fierce Pharma

MARCH 28, 2024

Authors: | Gain the competitive edge with accurate probability of success assessments to uncover undervalued companies and early-stage assets for acquisitions.

Biopharma

Biopharma Competition

Merck scores key FDA approval for pulmonary arterial hypertension drug Winrevair

Fierce Pharma

MARCH 26, 2024

After three years, the crown jewel of Merck’s $11.5 billion acqu | After three years, the crown jewel of Merck’s $11.5 billion acquisition of Acceleron is ready to pay dividends. With the FDA’s approval of Winrevair (sotatercept) to treat pulmonary arterial hypertension (PAH), Merck is set to launch the first disease-modifying treatment for the condition.

FDA

Bristol Myers Squibb cuts hundreds of Mirati staffers months after closing $5.8B buyout

Fierce Pharma

MARCH 26, 2024

Bristol Myers Squibb cuts hundreds of Mirati staffers months after closing $5.

With biopharma industry tuned in, Supreme Court hears arguments around medication abortion

Fierce Pharma

MARCH 26, 2024

In the wake of last year’s court decision to limit the FDA’s approval for the medication abortion pill mifepristone, many drugmakers, trade groups and even the U.S. | The Biden Administration and mifepristone’s manufacturer, Danco Laboratories, are getting their day in court, as they attempt to fight one of the most pivotal battles surrounding reproductive health since the Supreme Court overturned Roe v.

Medical

Medical Biopharma Manufacturing

Amgen, facing potential Enbrel price cap in Colorado, takes state's new drug affordability board to court

Fierce Pharma

MARCH 26, 2024

Amgen’s arthritis blockbuster Enbrel already owns an undesirable spot on the list o | The state's new Prescription Drug Affordability Review Board voted to subject the blockbuster arthritis med to an upper price limit, which Amgen calls a violation of the company's constitutional rights.

Prescription

Bluebird's Lyfgenia launch gains traction but shares tumble with report of accounting errors

Fierce Pharma

MARCH 26, 2024

Bluebird bio reported progress of its launch of three gene therapies and said it will have to refile financial statements because of accounting errors

Caring Cross, Brazil's Fiocruz team up to produce cell and gene therapies at a fraction of their cost in the US

Fierce Pharma

MARCH 26, 2024

Maryland non-profit Caring Cross has unveiled a partnership with the Brazilian government that's designed to provide access to advanced cell and gene therapies for diseases like leukemia, lymphoma | Maryland nonprofit Caring Cross has unveiled a partnership with the Brazilian government which is designed to provide access to advanced CAR-T and gene therapies for diseases like leukemia, lymphoma and HIV infection—and in the process provide a manufacturing model that demonstrates how to reduc

Government

Government Manufacturing

After transformation under new CEO, Leo Pharma touts innovation model and financial progress

Fierce Pharma

MARCH 12, 2024

Taking over as CEO for an aging company in dire financial straits and in need of a slimdown was a challenging assignment for Christophe Bourdon. | Taking over as CEO for an aging company in dire financial straits and in need of a slimdown was a challenging assignment for Christophe Bourdon. Under Bourdon’s watch, Leo Pharma is taking steps toward a rebound.

Pharma

Bluebird bio inks first Medicaid coverage agreement for sickle cell gene therapy, signing on with Michigan

Fierce Pharma

MARCH 11, 2024

Bluebird Bio has secured its first Medicaid outcomes-based agreement for its sickle cell disease gene therapy Lyfgenia, signing on with Michigan.

Viatris' launch plans scuttled as FDA rebuffs long-acting MS drug from partner Mapi

Fierce Pharma

MARCH 11, 2024

Viatris likely just lost one of its top product debuts for 2024, thanks to an FDA rejection of its partner Mapi Pharma’s application for a new version of Teva’s multiple sclerosis (MS) drug Co | Viatris likely just lost one of its top product debuts for 2024, thanks to an FDA rejection of its partner Mapi Pharma’s application for a new version of Teva’s multiple sclerosis (MS) drug Copaxone.

FDA

Despite pharma growth, Merck KGaA's CDMO slowdown plays into company's overall sales decline

Fierce Pharma

MARCH 7, 2024

After posting revenue increases for six straight years, including double-digit growth in 2021 and 2022, Merck KGaA took a hard fall last year, with its global sales

Sales

Sales Pharma

Eli Lilly flags bacteria, impurity concerns in fake and compounded versions of popular GLP-1 meds

Fierce Pharma

MARCH 7, 2024

With the swelling popularity of Eli Lilly’s diabetes med Mounjaro and its weight loss counterpart Zepbound, unauthorized copycats continue to emerge, posing a growing safety risk. | The company republished an open letter reiterating its commitment to taking legal action against scam sellers after discovering bacteria and impurities in some of the fraudulent meds.

Safety

As Imbruvica stumbles, BeiGene's Brukinsa steps up with FDA nod in follicular lymphoma

Fierce Pharma

MARCH 1, 2024

With a new FDA nod, BeiGene has filled the follicular lymphoma approval gap for BTK inhibitors. | BeiGene has filled the follicular lymphoma gap for BTK inhibitors with an FDA approval for Brukinsa about a year after AbbVie and Johnson & Johnson's Imbruvica stumbled in a phase 3 trial. But tough competition with CAR-T therapies and bispecifics lies ahead.

FDA

FDA Competition

Boehringer Ingelheim cuts monthly out-of-pocket inhaler prices to $35 for US patients

Fierce Pharma

MARCH 7, 2024

As one of Boehringer Ingelheim's asthma competitors catches scrutiny over pricing and access concerns, the company itself is taking steps to cut patient costs in the U.S. | Starting on June 1, patients will only have to shell out a maximum of $35 per month for Boehringer Ingelheim inhalers in the U.S.

Patients

Despite Leqembi's launch pains, Eisai projects Alzheimer's med will reach $8.8B in the long run

Fierce Pharma

MARCH 7, 2024

Despite weathering a host of launch challenges with Leqembi, Eisai still has big hopes for its amyloid-busting antibody in early Alzheimer’s disease. | By Eisai’s 2026 fiscal year—which ends in March 2027—the company figures its Alzheimer's disease drug Leqembi can bring home 290 billion Japanese yen (nearly $2 billion) in global revenues. Come fiscal year 2032, those sales could potentially swell to a whopping 1.3 trillion yen ($8.8 billion).

Sales

Amid patent fight, Sandoz biosimilars to Amgen bone blockbusters gain FDA nods

Fierce Pharma

MARCH 6, 2024

Two biosimilars to Amgen’s lucrative bone drugs Prolia and Xgeva have clinched approvals at the FDA, though ongoing patent litigation makes launch timing uncertain. | Sandoz has clinched FDA approvals for biosimilars to Amgen’s denosumab. Sandoz’s drugs mark the first approved denosumab biosimilars and treat all indications of the reference products.

FDA

AstraZeneca pledges £650M in UK investments to boost vaccine capabilities, expand near HQ

Fierce Pharma

MARCH 6, 2024

AstraZeneca CEO Pascal Soriot, who has been critical of the U.K.’s business environment for the life sciences industry, is directing a big chunk of money into the Big Pharma’s home country. | AstraZeneca CEO Pascal Soriot, who has been critical of the U.K.’s business environment for the life sciences industry, is directing £650 million into the Big Pharma’s home country.

With Sanofi left as the lone supplier of tetanus shots in the US, CDC warns of shortage

Fierce Pharma

MARCH 1, 2024

It’s time to add another vaccine to the shortage list in the U.S. | It’s time to add another vaccine to the shortage list in the United States as the CDC has urged healthcare providers to conserve their supply of tetanus shots. The warning from the national public health agency comes after one of the two providers of tetanus shots in the U.S., MassBiologics, discontinued production of its tetanus and diphtheria vaccine.

Healthcare Provider

Healthcare Provider Healthcare Healthcare

Ahead of strategy reveal, Bayer taps activist investor Jeffrey Ubben for board seat

Fierce Pharma

MARCH 1, 2024

In the latest shake-up amid waves of changes at Bayer, the company is planning to add new expertise to its board room, including a prominent activist investor. | The company's supervisory board proposed the appointments of activist investor Jeffrey Ubben, legal expert Lori Schecter and biotech leader Nancy Simonian, M.D. Bayer also swapped in a new head of its consumer health division.

Moderna lays off parts of manufacturing team after resizing COVID footprint

Fierce Pharma

MARCH 1, 2024

Moderna is laying off employees within its manufacturing unit, with the move tied to a resizing of its COVID production work. | Moderna is laying off some employees within its manufacturing unit after shaving COVID production costs. The company previously disclosed plans to rightsize its COVID vaccine production footprint.

Manufacturing

CAR-T boxed warnings: What comes next?

Fierce Pharma

MARCH 1, 2024

The FDA recently asked the six marketed CAR-T therapies to add a new boxed warning item on their labels to reflect the risk of secondary T-cell cancers. | The FDA recently asked the six marketed CAR-T therapies to add a new boxed warning item on their labels to reflect the risk of secondary T-cell cancers. This week on "The Top Line," Fierce Pharma’s Angus Liu talks with regulatory experts to understand the rationale behind the FDA’s decision and to discuss its implications for CAR-T c

FDA

FDA Marketing

Fierce Pharma Asia—BeiGene's 1,400 new hires; BMS' India innovation hub; Evrenzo's China growth

Fierce Pharma

FEBRUARY 29, 2024

BeiGene expanded its global workforce by 1,400 over the past 12 months amid fast revenue growth. | BeiGene expanded its global workforce by 1,400 over the past 12 months. Bristol Myers Squibb opened a large innovation hub in India. AstraZeneca has decided to hold onto Evrenzo in China and Korea while returning rights to FibroGen in the U.S.

Pharma

Kyowa Kirin plans $200M plant in NC, where it'll hire 100-plus new employees

Fierce Pharma

MARCH 1, 2024

North Carolina has proved an attractive destination for biopharma companies large and small in recent years, ginning up investments and site commitments from the likes of Eli Lilly, Fujifilm Diosyn | North Carolina has proved an attractive destination for biopharma companies large and small in recent years, ginning up investments and site commitments from the likes of Eli Lilly, Fujifilm Diosynth, Thermo Fisher and Amgen.

Biopharma

Novavax dodges COVID vaccine refund by settling Gavi arbitration for up to $400M

Fierce Pharma

FEBRUARY 21, 2024

On the heels of a turbulent 2023 in which Novavax’s very existence was at stake, the beleaguered vaccine maker has new reason to be optimistic about the future. | Novavax has reached a settlement with Gavi, the Vaccine Alliance ending arbitration tied to a 2021 advance purchase agreement around its prototype COVID-19 vaccine NVX-CoV2373. Had Novavax lost the arbitration, the company might have had to refund nearly $700 million.

GSK’s long-acting HIV med Cabenuva beats daily therapy in patients who've faced adherence hurdles

Fierce Pharma

FEBRUARY 20, 2024

GSK’s long-acting HIV regimen Cabenuva has already shown it works as well as daily oral therapies in patients who have the virus under control. | GSK’s long-acting HIV regimen Cabenuva has already shown it works as well as daily oral therapies in patients who have the virus under control. Now, the injection has beaten daily drugs in individuals who’ve faced issues adhering to their medications.

Patients

Patients Medical

FDA approves Iovance’s Amtagvi as first T-cell therapy for a solid tumor

Fierce Pharma

FEBRUARY 16, 2024

The T-cell therapy treatment class, which has transformed the treatment of certain blood cancers, has now reached the solid tumor field thanks to an FDA approval for a first-of-its-kind immunothera | The T-cell therapy treatment class, which has transformed the treatment of certain blood cancers, has now reached the solid tumor field thanks to an FDA approval for a first-of-its-kind immunotherapy developed by Iovance Biotherapeutics.

FDA

In wake of Reata buyout, Biogen's key launch Skyclarys passes muster in EU

Fierce Pharma

FEBRUARY 12, 2024

Roughly half a year after Biogen’s $7.3 billion buyout of rare disease specialist Reata Pharmaceuticals, the companies’ blockbuster bid for Reata’s Friedreich’s ataxia (FA) drug Skyclarys is starti | Roughly half a year after Biogen’s $7.3 billion buyout of rare disease specialist Reata Pharmaceuticals, the companies’ blockbuster bid for Reata’s Friedreich’s ataxia (FA) drug Skyclarys is starting to take shape.

Pharmaceutical

Fool me thrice: FDA blasts Chinese API maker for 'misleading' investigators, making up testing records

Fierce Pharma

FEBRUARY 12, 2024

When it comes to what not to do during an FDA inspection of your drug ingredient manufacturing facility, having the plant’s quality control chief intentionally give investigators the runaround by f | When it comes to what not to do during an FDA inspection of your drug ingredient manufacturing facility, having the plant’s quality control chief intentionally give investigators the runaround by fibbing about the existence of testing logs ranks high on the list.

FDA

FDA Manufacturing

With Merck, J&J and BMS CEOs set to testify, Sanders releases scathing report on drug prices

Fierce Pharma

FEBRUARY 6, 2024

Two days ahead of a Senate hearing in which CEOs from three pharma majors will testify, Sen. | Two days ahead of a Senate hearing in which CEOs from three pharma majors will testify, Sen. Bernie Sanders has released a report shedding light on the system that allows the companies to charge more for drugs in the U.S. than in any other country.

Pharma

FTC calls for ‘expansive and flexible’ use of march-in rights to rein in drug prices

Fierce Pharma

FEBRUARY 6, 2024

As the U.S. | The U.S. Federal Trade Commission supports a draft guidance that would allow drug pricing be factored into consideration of the government's march-in rights. And the antitrust watchdog is advocating for further scrutiny around "patent thickets" to complement the march-in provision.

Government

Despite Vyvanse’s loss of exclusivity, Takeda treads water thanks to launch momentum

Fierce Pharma

FEBRUARY 1, 2024

Despite the recent loss of exclusivity on Takeda's ADH | As Vyvanse generics take a chunk out of Takeda's sales, the company is hopeful its roster of new drugs, including its dengue fever vaccine Qdenga, can keep revenues intact.

Sales

Who's No. 1? With $25B in sales, Merck's Keytruda looks to be the top-selling drug of 2023

Fierce Pharma

FEBRUARY 1, 2024

With Merck reporting a whopping $25 billion sales haul for | With Merck reporting a whopping $25 billion sales haul for Keytruda on Thursday, the PD-1 cancer superstar appears to be the world’s top-selling drug in 2023. Keytruda looks set to take over the top spot from Pfizer and BioNTech’s Comirnaty, which ruled the previous two years, scoring sales of $55.9 billion in 2022 and $55.1 billion in 2021.

Sales

Pfizer's layoff campaign ramps back up with dozens of SF-area cuts expected next month

Fierce Pharma

JANUARY 29, 2024

The start of the new year doesn’t seem to have dulled the zeal of Pfizer’s global cost-cutting campaign, which has already left hundreds of jobs in its wake. | Come mid-February, Pfizer will lay off some 52 employees at a facility in South San Francisco, according to a recent Worker Adjustment and Retraining Notification Act alert. The site is the former headquarters of Global Blood Therapeutics.

Grifols files lawsuit against hedge fund for making 'false and misleading statements'

Fierce Pharma

JANUARY 29, 2024

Grifols has filed a lawsuit against Gotham City that accuses the hedge fund of manipulating "the value of Grifols’ stock for their own monetary gain.

Providing a Pathway to Patient Connectivity and Adherence

Fierce Pharma

JANUARY 24, 2024

Today, gaining consistent access to life-saving medications can be a significant hurdle that many patients must learn to navigate. | Specialty therapy patients require accessible prescription management solutions that can simplify communication, improve access, and increase adherence.

Patients

Patients Prescription Management Medical

Fierce Pharma

Ahead of Alnylam's key heart disease readout, experts say Pfizer rival would be hard to displace

Biogen CEO Viehbacher sees 2023 pay fall to $4M after massive welcome package

Trending Sources

With Vyvgart 'firing' in myasthenia gravis, argenx lays launch plans for next potential autoimmune approval: CEO

Another Caplyta trial win moves Intra-Cellular closer to FDA filing in major depressive disorder

J&J reports strong sales numbers for Tecvayli, bolstering company's multiple myeloma 'stronghold'

Eisai, Biogen's injectable Leqembi delayed as FDA asks for more data

Teva snares up to $150M in Abingworth funding to propel late-stage asthma rescue inhaler

AstraZeneca's rare disease add-on therapy Voydeya scores FDA nod

Aurisco Pharmaceutical Launches State-of-the-Art Manufacturing Facility for GLP-1 Peptides

Patented AI Platform Identifies Promising Early-Stage BioPharma Assets and Companies

Merck scores key FDA approval for pulmonary arterial hypertension drug Winrevair

Bristol Myers Squibb cuts hundreds of Mirati staffers months after closing $5.8B buyout

With biopharma industry tuned in, Supreme Court hears arguments around medication abortion

Amgen, facing potential Enbrel price cap in Colorado, takes state's new drug affordability board to court

Bluebird's Lyfgenia launch gains traction but shares tumble with report of accounting errors

Caring Cross, Brazil's Fiocruz team up to produce cell and gene therapies at a fraction of their cost in the US

After transformation under new CEO, Leo Pharma touts innovation model and financial progress

Bluebird bio inks first Medicaid coverage agreement for sickle cell gene therapy, signing on with Michigan

Viatris' launch plans scuttled as FDA rebuffs long-acting MS drug from partner Mapi

Despite pharma growth, Merck KGaA's CDMO slowdown plays into company's overall sales decline

Eli Lilly flags bacteria, impurity concerns in fake and compounded versions of popular GLP-1 meds

As Imbruvica stumbles, BeiGene's Brukinsa steps up with FDA nod in follicular lymphoma

Boehringer Ingelheim cuts monthly out-of-pocket inhaler prices to $35 for US patients

Despite Leqembi's launch pains, Eisai projects Alzheimer's med will reach $8.8B in the long run

Amid patent fight, Sandoz biosimilars to Amgen bone blockbusters gain FDA nods

AstraZeneca pledges £650M in UK investments to boost vaccine capabilities, expand near HQ

With Sanofi left as the lone supplier of tetanus shots in the US, CDC warns of shortage

Ahead of strategy reveal, Bayer taps activist investor Jeffrey Ubben for board seat

Moderna lays off parts of manufacturing team after resizing COVID footprint

CAR-T boxed warnings: What comes next?

Fierce Pharma Asia—BeiGene's 1,400 new hires; BMS' India innovation hub; Evrenzo's China growth

Kyowa Kirin plans $200M plant in NC, where it'll hire 100-plus new employees

Novavax dodges COVID vaccine refund by settling Gavi arbitration for up to $400M

GSK’s long-acting HIV med Cabenuva beats daily therapy in patients who've faced adherence hurdles

FDA approves Iovance’s Amtagvi as first T-cell therapy for a solid tumor

In wake of Reata buyout, Biogen's key launch Skyclarys passes muster in EU

Fool me thrice: FDA blasts Chinese API maker for 'misleading' investigators, making up testing records

With Merck, J&J and BMS CEOs set to testify, Sanders releases scathing report on drug prices

FTC calls for ‘expansive and flexible’ use of march-in rights to rein in drug prices

Despite Vyvanse’s loss of exclusivity, Takeda treads water thanks to launch momentum

Who's No. 1? With $25B in sales, Merck's Keytruda looks to be the top-selling drug of 2023

Pfizer's layoff campaign ramps back up with dozens of SF-area cuts expected next month

Grifols files lawsuit against hedge fund for making 'false and misleading statements'

Providing a Pathway to Patient Connectivity and Adherence

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