| Date | Title | Description |
| 06.08.2024 | Back-to-school shopping? Here's one item to add to your cart | Sorry, but your browser does not support the video tag.
(BPT) - Do you have a teenager or young adult heading back to school this year? Are you looking for peace of mind that they will stay safe? While picking up school supplies, clothing, ... |
| 29.03.2023 | FDA approves overdose-reversing Narcan for over-the-counter sale | The U.S. Food and Drug Administration has approved Narcan, an overdose-reversing nasal spray, for over-the-counter, non-prescription sale, the agency announced Wednesday. The FDA green light marks the first naloxone product approved for use... |
| 25.01.2023 | Making naloxone available over the counter won’t solve the overdose crisis — but it will help | The Food and Drug Administration aims to conduct priority reviews of at least two product applications for granting over-the-counter status to intranasal formulations of naloxone, an overdose-reversal drug.
Naloxone prevents overdose deaths... |
| 17.05.2022 | Presenting a live Endpoints News event: Managing a biotech in turbulent times | Vertex Pharmaceuticals has been one of the buzzier names in the bustling Boston biotech scene, but now the company is looking to vault to number one status — at least in terms of physical footprint.
At a ribbon cutting on Tuesday for its ne... |
| 16.05.2022 | Aldevron and Inscripta ink manufacturing deal for CRISPR Type-V nuclease | A plan to broaden access to CRISPR has attracted a chunk of funding and is now seeing its wings spread.
Fargo-based DNA and mRNA producer Aldevron has signed an agreement with life sciences company Inscripta to manufactu... |
| 16.05.2022 | Emergent inks $225M cash smallpox deal as Chimerix implodes on reorg, FDA trouble | Emergent BioSolutions has made a name for itself ever since the late 1990s by making drugs that are needed by the US government. Monday, it took that a step further, as it entered a deal with Chimerix to acquire the exclusive ... |
| 16.05.2022 | Roche lays out access ambitions in its ESG strategies, including innovation and value goals | Roche laid out its ambitions in the social part of its environmental, social and governance (ESG) strategy on Monday centered on access to its drugs and diagnostics.
The Roche inaugural Access to Healthcare investor ... |
| 16.05.2022 | Agios CSO to depart amid layoffs as biotech looks for new drugs to license or acquire | A week after Seagen revealed that longtime CEO Clay Siegall was on leave due to an allegation of domestic violence, he has resigned.
Since that shocking revelation, more details about the claims have emerged into the public eye. As Endpoint... |
| 16.05.2022 | Aldevron and Inscripta ink manufacturing deal for CRISPR Type-V nuclease | Just a few weeks after Bristol Myers Squibb and Nektar put the kibosh to their combo study of Opdivo and bempeg for metastatic urothelial cancer, one of the last big flameouts that convinced the pharma giant to squash their multibillion-dol... |
| 16.05.2022 | Real world evidence: Lessons learned from an FDA pilot show the limits of emulating RCTs | Only about half of a select group of clinical trials could be well-emulated with available real world evidence, according to the newly discussed results of an FDA pilot program.
The FDA-funded program, known as RCT-DUP... |
| 16.05.2022 | Indian drugmaker seeks to toss 'bloated' billion-dollar lawsuit over Covid vaccine candidate | Eli Lilly has clinched a key OK for tirzepatide, drawing the curtain on what it hopes will be a major cardiometabolic franchise and a serious rival to a megablockbuster from Novo Nordisk.
With the FDA approval, Lilly will start marketing ti... |
| 16.05.2022 | Moderna blindsided by investigation into former CFO Jorge Gomez, company says | It’s been days since Moderna sent its new CFO Jorge Gomez packing — after just one day on the job — over an investigation launched by his former employer. Although that probe was initiated back in March, Moderna says it had... |
| 16.05.2022 | Agios CSO to depart amid layoffs as biotech looks for new drugs to license or acquire | SEATTLE — It’s a cloudy Thursday afternoon in mid-July and David Baker is reclining into the futon in his corner office at the University of Washington, arms splayed out like a daytime talk show host as he coaches another one of his postdoc... |
| 16.05.2022 | Covid-19 roundup: Synairgen turns to post-hoc analyses after failed drug trial; EU terminates Valneva vaccine contract | After halting enrollment in an NIH-led Phase II/III study, and failing an earlier Phase III trial, UK-based Synairgen’s Covid-19 drug did show some promise in some select subgroups, the company said in its presentation of a ... |
| 16.05.2022 | Billionaire Athira backer Ric Kayne suspends activist campaign — but shareholders can still vote for him | Following the ouster of Leen Kawas at the Alzheimer’s-focused biotech Athira, a minority stakeholder with ties to the former founder launched an activist attack to replace her successor. But on Monday, the billionaire inv... |
| 01.10.2021 | Pfizer loses closely watched court case on kickbacks and subsidizing drugs | Three months removed from the completion of its last renovation, a Thermo Fisher location is about to change again.
Thermo Fisher will spend $82.5 million to expand its St. Louis, MO operations and add another 169 jobs to its drug substance... |
| 01.10.2021 | Emergent lands another big money contract from BARDA for anthrax | After negative feedback from the FDA, the loss of business with AstraZeneca and the disruption to the Covid-19 supply chain, the US government has not lost faith in Emergent BioSolutions.
Emergent has landed a contract wort... |
| 01.10.2021 | Pfizer loses closely watched court case on kickbacks and subsidizing drugs | When Cytiva decided it would play a role in the Covid-19 pandemic, it moved quickly to open new manufacturing sites and adapt existing ones. Now, the company will send that investment overseas as the company announced a multimillion-dollar ... |
| 01.10.2021 | Pfizer loses closely watched court case on kickbacks and subsidizing drugs | Confirming days of rumors and insider leaks, Merck will acquire Acceleron Pharma and its lead PAH drug sotatercept for $11.5 billion, the companies said Thursday.
The acquisition doesn’t come at much of a premium: Shares of $XLRN closed Wed... |
| 30.09.2021 | Eli Lilly issues response to Form 483 at Indianapolis plant | After an Aug. 12 dated Form 483 called out Eli Lilly’s Indianapolis sterile injectables plant for several lapses in quality, the company has issued a 95-page response.
Seven key observations came out of the inspectio... |
| 30.09.2021 | Otsuka puts nearly $1 billion on the line for four neuropsychiatric candidates from Sunovion | It’s been six years since Otsuka got its Lundbeck-partnered antipsychotic Rexulti approved to treat schizophrenia in the US. Now, the company has its sights set on a new approach for the difficult-to-treat disease — and i... |
| 30.09.2021 | Bristol Myers reports shortage of chemo drug abraxane; Sartorius more than doubles capacity with Michigan expansion | Manufacturing delays have led to a shortage in abraxane, Bristol Myers Squibb says.
The announcement comes on the heels of the FDA shooting down a petition to stall generic version of the drug. Five years after the petiti... |
| 16.09.2021 | Emergent gets a chance to redeem itself in mRNA vaccine deal with Providence Therapeutics | One of the most notorious names in American drug manufacturing has landed a contract with a Canadian drugmaker looking to make waves in the mRNA Covid-19 vaccine game and fill in the gaps the two big mRNA companies have... |
| 29.07.2021 | After a months-long halt on production, Emergent is back up and running in Baltimore | It’s been a long time since Emergent BioSolutions has been able to produce Covid-19 vaccines at its Baltimore Bayview plant, but the FDA has given the company the go-ahead to resume production, a company spokesman confirmed ... |
| 19.04.2021 | The doctor is in: Trump insider Ben Carson joins NASH player Galectin as a 'special consultant,' part-time spokesman | As Goldman Sachs’ top pharmaceutical analyst, Jami Rubin was known for asking the tough questions. Now, as she takes the lead on EQRx’s mission to rewrite the rules of drug pricing, we’ll see how good her answers are.
Rubin made the jump to... |
| 19.04.2021 | FDA slaps a hold on Moffitt’s next-gen CAR-T as regulators demand another delay on clinical work — shares crater | Close to a year-and-a-half after tapping the brakes on one of its preclinical programs to do some added genetic engineering work on their next-gen CAR-T, Anixa $ANIX Therapeutics says the regulatory light is flashing red ... |
| 19.04.2021 | New Kaiser analysis shows how limiting price negotiations to targeted drugs may better focus upcoming legislation | Emergent BioSolutions has had a tough month: First, the CDMO ruined 15 million doses of J&J’s Covid-19 vaccine in March and then suffered the ignominy of the FDA seizing the reins. Now, as the agency receives a full accounting of the si... |
| 19.04.2021 | The doctor is in: Trump insider Ben Carson joins NASH player Galectin as a 'special consultant,' part-time spokesman | In the few short months since President Donald Trump left office, his former department heads are reportedly having a difficult time finding employment. But for Ben Carson, Trump’s former housing secretary, that’s not a... |
| 19.04.2021 | Seagen gets August PDUFA for Padcev expansions; Adaptate pulls in new cash for gamma delta T cell antibodies | Seagen is riding the wave of two new priority reviews straight to the FDA.
The Bothell, WA-based biotech and their partners at Astellas announced Monday that two supplemental BLAs for Padcev had been accepted by US regula... |
| 31.03.2021 | Roughly 15 million doses of the Johnson & Johnson vaccine were ruined because of a factory mixup, report says | The first boxes of the Johnson & Johnson Covid-19 vaccine are loaded into a box for shipment from the McKesson facility in Shepherdsville, Kentucky on March 1, 2021. Timothy Easley/AFP via Getty Images
A mixup in a Baltimore factory rui... |
| 13.02.2021 | Another Keytruda combo tops standard of care in advanced kidney cancer, posing new test for Bristol's I/O med | Another BARDA contract designed to service America’s Covid-19 vaccine needs has been deployed.
The White House-led initiative designed to bankroll development to bring a vaccine to the American public by this fall — Operation Warp Speed — h... |
| 01.04.2020 | Coronavirus Business Tracker: How The Private Sector Is Fighting The Covid-19 Pandemic | Alain Mérieux, founder of BioMérieux.AFP via Getty Images |
| 16.08.2017 | Feds offer up a new bonus plan for the R&D work they often pay for | As the nearly 1,000-page 21st Century Cures Act is implemented in phases, the full impact of the law is just beginning to be realized, and for one provision, the law has created a new program that rewards biopharmas for ... |
