Manufacturing: Page 11
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US government promises Maryland drug manufacturer $628M to make coronavirus vaccines
The cash will secure manufacturing capacity at three Emergent sites for coronavirus vaccine developers, part of a sweeping government-led effort to make a protective treatment available as soon as possible.
By Ned Pagliarulo • June 2, 2020 -
Permission granted by BioNTech SE
Facing vial shortage, pharmas explore workarounds for coronavirus vaccines
"There's not enough vials in the world," said AstraZeneca's CEO on Thursday. Procuring enough to hold the billions of vaccine doses needed is yet another headache for coronavirus drugmakers to solve.
By Ned Pagliarulo • May 28, 2020 -
Jacob Bell/BioPharma Dive
Contaminated diabetes drugs raise red flag for FDA oversight
The Food and Drug Administration is reaching out to drug manufacturers after finding some metformin pills were contaminated with the carcinogen NDMA.
By Jacob Bell • Updated May 29, 2020 -
National Institute of Allergy and Infectious Disease. (2020). "Novel Coronavirus SARS-CoV-2" [Microscope image]. Retrieved from https://www.flickr.com/photos/nihgov/49565158853/.
Novartis teams with Mass. Eye & Ear to join coronavirus vaccine chase
The Swiss pharma has become the latest large drugmaker to enter the worldwide race to develop a vaccine for COVID-19, tapping a project developed by gene therapy experts at the Massachusetts Eye and Ear Hospital.
By Jonathan Gardner • May 28, 2020 -
Courtesy of Novavax, Australian Broadcasting Corporation
Novavax buys more manufacturing capacity as first COVID-19 vaccine test begins
The Maryland biopharma has acquired a Czech vaccine developer for $167 million, gaining a facility in Europe that will boost its COVID-19 vaccine production capabilities.
By Kristin Jensen • May 28, 2020 -
How tariffs disrupted the COVID-19 medical supply chain
Months into the pandemic, the U.S. faces an ongoing shortage of PPE and some of it is still subject to tariffs.
By Deborah Abrams Kaplan • May 27, 2020 -
Permission granted by Gilead Sciences
Bangladesh pharma claims to be first to launch generic remdesivir
Beximco, which wasn't one of five drugmakers to license the coronavirus treatment from Gilead, says it can make a copycat version under World Trade Organization rules.
By Jonathan Gardner • May 21, 2020 -
Little-known drug manufacturer gets big contract for COVID-19 response
Through BARDA, the U.S. government has promised hundreds of millions of dollars to Phlow, a self-declared public benefit company that aims to secure a U.S.-based supply chain for essential medicines.
By Jacob Bell • May 19, 2020 -
Craighead, Shealah. (2020). "President Trump Delivers an Update on Vaccine Development" [Photograph]. Retrieved from Flickr.
'Operation Warp Speed,' unveiled by Trump, aims for coronavirus vaccine by year's end
Speeding the development and production of vaccines will be the project's principal aim, but it will also involve readying cold chain storage as well as supplies of needed vials and syringes.
By Ned Pagliarulo • May 15, 2020 -
Permission granted by Gilead Sciences
Gilead licenses COVID-19 drug to 5 generics companies
The agreements would allow Mylan, Cipla and others to make remdesivir and distribute it to 127 countries. A consumer advocacy group, though, criticized Gilead for leaving many countries out.
By Jacob Bell • May 13, 2020 -
Thermo Fisher to invest $180M in new gene therapy plant
The planned facility, to be built in Massachusetts, will rival in size a gene therapy plant in Texas owned by CDMO competitor Lonza.
By Kristin Jensen • May 13, 2020 -
Surprise setback for Bristol, Bluebird as FDA rejects cell therapy application
In a "refuse-to-file" letter, the regulator requested additional documentation of the companies' manufacturing processes for the CAR-T treatment, ide-cel.
By Ben Fidler , Ned Pagliarulo • May 13, 2020 -
Jacob Bell/BioPharma Dive
FDA, CDC drawing up plan to restart routine plant inspections
A phased approach is in the works to reintroduce oversight that's been on hold in the U.S. and abroad since March.
By Nick Paul Taylor • May 12, 2020 -
Permission granted by Gilead Sciences
Trump administration: States to decide which hospitals get Gilead's COVID-19 drug
HHS will distribute to states some of the roughly 600,000 vials of remdesivir Gilead is donating to the U.S., but said decisions on which hospitals receive the drug will be made by state health agencies.
By Ned Pagliarulo • May 11, 2020 -
Moderna plans earlier start to late-stage test of coronavirus vaccine
A Phase 3 trial of Moderna's experimental vaccine could begin in early summer, several months sooner than what was already an ambitious target for starting this fall.
By Ned Pagliarulo • May 7, 2020 -
Permission granted by BioNTech SE
Pfizer, BioNTech launch U.S. trial of coronavirus vaccine
Initial vaccine data are expected within weeks as biotech and pharma companies intensify their search for a way to prevent the spread of COVID-19.
By Jonathan Gardner • May 5, 2020 -
Moderna, with government cash, taps Lonza to make 1 billion doses of COVID-19 vaccine
The deal gives Moderna more manufacturing might to make sufficient supplies of its experimental coronavirus vaccine, which it's advancing quickly.
By Ben Fidler • May 1, 2020 -
J&J contracts with Catalent to boost coronavirus vaccine production
The partnership is the second J&J has inked in recent weeks as it prepares sufficient capacity to supply 1 billion doses of its experimental vaccine.
By Kristin Jensen • April 30, 2020 -
Master Sgt. Hecht, Matt. (2020). [Photograph]. Retrieved from Flickr.
3M cites supply chain shift for getting grip on pandemic demand
Demand for N95 masks and healthcare equipment is on the rise, while other products are less needed, forcing the manufacturing giant to pivot quickly.
By Matt Leonard • April 28, 2020 -
Permission granted by Merck KGaA
Merck KGaA to spend $110M on new gene therapy facility in California
The investment continues a spate of build-outs by Merck KGaA, which, like its contracting peers, sees an opportunity in the fast-growing gene therapy field.
By Kristin Jensen • April 23, 2020 -
Thermo Fisher, Roche boosted by COVID-19 diagnostics, but warn of routine testing declines
Both companies disclosed big first quarter hits to business in China, and said impacts in the U.S. and Europe could be more apparent as the year goes on.
By Nick Paul Taylor • April 22, 2020 -
Master Sgt. Hecht, Matt. (2020). [Photograph]. Retrieved from Flickr.
Manufacturers call on government to help with production pivots to PPE
NAM, a top trade group, is lobbying for the federal government to provide more incentives for businesses that switch to producing essential goods like PPE.
By Matt Leonard • April 22, 2020 -
US government to back Moderna's coronavirus vaccine with up to $483M
The BARDA grant will allow Moderna to hire 150 more staff and accelerate testing of its vaccine, which entered a Phase 1 study in March and could soon move to a mid-stage trial.
By Ned Pagliarulo • Updated April 17, 2020 -
Fujifilm ramps up production of flu drug Avigan for COVID-19
Use of the drug, which isn't approved in the U.S., is controversial without fuller data showing evidence it works in treating the disease.
By Kristin Jensen • April 16, 2020 -
Philips launches scaled-down ventilator, inks production deals to boost output
The medtech has allied with smaller players Flex and Jabil, aiming to produce 4,000 units per week by the third quarter.
By Nick Paul Taylor • April 15, 2020
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