- Merck & Co expects a research-and-development charge of about $10.3 billion, or $4 per share, this year as the drugmaker accounts its deal for Prometheus Biosciences Inc as an asset acquisition, CFO Caroline Litchfield said.
The deal is expected to hit Merck's profit by 25 cents per share in the first 12 months, Litchfield said in an investor conference call on Monday.
The deal is expected to close in the third quarter.
Merck on Sunday agreed to buy Prometheus for about $10.8 billion to build up its presence in immunology. Net of Prometheus' cash balance, the price paid comes to $10.3 billion.
(Reporting by Raghav Mahobe and Leroy Leo in Bengaluru; Editing by Devika Syammnath)...
LAGOS - Nigeria's food and drug regulator has granted provisional approval to Oxford University's R21 malaria vaccine, it said on Monday, following a similar announcement by Ghana last week.
The approval is unusual as it comes before the publication of final-stage trial data for the vaccine, which aims to curb the mosquito-borne disease that kills more than 600,000 people each year, most of them African babies and children.
"A provisional approval of the R21 Malaria Vaccine was recommended and this shall be done in line with the WHO's Malaria Vaccine Implementation Guideline," said Nigeria's National Agency for Food and Drug Administration and Control (NAFDAC).
"While granting the approval, the Agency has also communicated the need for expansion of the clinical trial conducted to include a phase 4 clinical trial/Pharmacovigilance study to be carried out in Nigeria," it said in a statement by its director-general, Mojisola Christianah Adey...
WASHINGTON - The U.S. Supreme Court on Monday declined to hear Novartis Pharmaceuticals Corp's bid to revive a key patent on its blockbuster multiple sclerosis drug Gilenya that was invalidated amid a legal dispute with China's HEC Pharm Co Ltd.
The justices turned away an appeal by Novartis of a lower court's decision to cancel the patent, a ruling that paved the way for some generic versions of Gilenya.
(Reporting by Blake Brittainl Editing by Will Dunham)...
By John Kruzel
WASHINGTON - The U.S. Supreme Court on Monday declined to hear a bid by Sanofi SA to revive its antitrust lawsuit accusing rival pharmaceutical company Viatris Inc of illegally monopolizing the market with its EpiPen auto-injector, a device used to treat severe allergic reactions.
The justices turned away Sanofi's appeal of a lower court's ruling rejecting the French company's claim that Canonsburg, Pennsylvania-based Viatris had effectively cornered the market through exclusive deals with prescription drug intermediaries.
(Reporting by John Kruzel; Editing by Will Dunham)...
By Horacio Soria and Juan Carlos Bustamante
BUENOS AIRES - Argentine, fighting one of its worst outbreaks of dengue in recent years, is sterilizing mosquitoes using radiation that alters their DNA before releasing them into the wild.
The South American country has this year recorded over 41,000 cases of the disease transmitted by mosquitoes, far above the equivalent level in previous years of major outbreaks in 2020 and 2016, government data showed.
"This mosquito, due to the rise in temperature in our country and the world... is able to spread more. Their population keeps on moving further south," said National Atomic Energy Commission (CNEA) biologist Marianela Garcia Alba.
To fight back, CNEA biologists have been experimenting with atomic sterilization since 2016. They are sterilizing 10,000 males per week and aim to increase that to 500,000. They expect to release the first batch of sterilized males in November....
MADRID - A Spanish hospital carried out a lung transplant using a pioneering technique with a robot and a new access route that no longer requires separating the ribs and opening up the chest, experts said on Monday.
Surgeons at Vall d'Hebron hospital in Barcelona used a four-arm robot dubbed "Da Vinci" to cut a small section of the patient's skin, fat and muscle to remove the damaged lung and insert a new one through an eight-centimetre incision in the lower part of the sternum, just above the diaphragm.
The new procedure is less painful for the patient, they said, as the wound closes easily, and is safer than the traditional method which requires a 30-centimetre incision and a very delicate post-operative period.
"We believe it is a technique that will improve patients' life quality, the post-surgery period and reduce pain. We hope this technique will eventually spread to more centres," Albert Jauregui, head of the Thoracic Surgery and...
By Michael Erman
-Merck & Co said on Sunday it will buy Prometheus Biosciences Inc for about $10.8 billion, picking up a promising experimental treatment for ulcerative colitis and Crohn's disease and building up its presence in immunology.
Merck will pay $200 per share for the California-based biotechnology company that specializes in treatments for autoimmune diseases. That represents a 75% premium to the $114.01 closing price for Prometheus shares on Friday.
"This is allowing us to move into immunology in a strong way and will allow us sustainable growth, we think, well into the 2030s given the long patent life," Merck Chief Executive Robert Davis said in an interview.
Davis said the Prometheus drug, PRA023, being developed to treat ulcerative colitis, Crohn’s disease, and other autoimmune conditions, could be a multibillion-dollar seller for Merck. He said the recent release of encouraging Phase II clinical trial results...
By Julie Steenhuysen and Michael Erman
- An experimental mRNA vaccine developed by Moderna Inc combined with Merck & Co's blockbuster immunotherapy Keytruda cut the risk of death or recurrence of the most deadly skin cancer by 44% compared Keytruda alone, U.S. researchers reported at a medical meeting on Sunday.
The findings suggest that adding a personalized cancer vaccine based on mRNA technology to Keytruda, which revs up the immune response, could prolong the time patients have without recurrence or death, said Dr. Jeffrey Weber of the NYU Langone Perlmutter Cancer Center, who presented the findings.
"From a general cancer therapeutic standpoint, this is a potential major breakthrough," Dr. Ryan Sullivan, a melanoma expert at Mass General Cancer who worked on the study, said in a statement.
The results, presented at American Association for Cancer Research meeting in Orlando, Florida, add data details to partial fin...
- Six additional laboratory-confirmed cases of Marburg disease have been reported in Equatorial Guinea, bringing the total number to 15, the World Health Organization (WHO) said on Saturday.
(Reporting by Shivani Tanna in Bengaluru; editing by Jason Neely)...
LONDON - Nurses in England have voted to reject the government's new pay deal, their trade union said, setting out further strikes that will put the National Health Service under more strain as nurses hold out for a higher wage offer.
About 54% of nurses who took part in a ballot voted to reject the pay deal, the Royal College of Nursing (RCN) - who had recommended members accept the deal - said on Friday. The turnout was 61% of eligible members.
The RCN said its members would stage a round-the-clock 48-hour strike from April 30, which for the first time will be joined by nursing staff from emergency departments, intensive care units, cancer care and other services that were previously exempt.
The result represents a setback for Prime Minister Rishi Sunak's government, which has been dealing with pay disputes involving hundreds of thousands of striking public workers as wages fail to keep up with double-digit inflation....
By Brendan Pierson
- New court-imposed restrictions on the abortion pill mifepristone could cut off access to the drug entirely for months, the Biden administration and the drug's distributor, Danco Laboratories, said in petitions asking the U.S. Supreme Court to lift the curbs.
Marketing the drugs under the conditions imposed by the 5th U.S. Circuit Court of Appeals on Wednesday will require a new approval from the U.S. Food and Drug Administration and new labeling, they said.
Danco, whose sole product is the abortion pill, said that if the Supreme Court does not act, it may have to halt its operations.
The FDA declined to comment. Danco could not immediately be reached for comment.
Following the 5th Circuit's ruling, mifepristone must be prescribed and dispensed by a doctor in person over multiple visits and can only be used only within the first seven weeks of pregnancy, restoring restrictions that the FDA...
CHICAGO - The U.S. government is testing several potential bird flu vaccines for poultry, officials said on Friday, after more than 58 million chickens, turkeys and other birds have died in the nation's worst outbreak ever.
The trials, conducted by the U.S. Department of Agriculture's (USDA) Agricultural Research Service, are the first step in a lengthy process toward the possible use of vaccines to protect poultry from the lethal virus. There is no guarantee the government will ultimately approve their use.
Bird flu, also known as highly pathogenic avian influenza (HPAI), has killed hundreds of millions of birds around the world, raising interest in vaccines. The virus is largely spread by wild birds that transmit it to poultry.
Initial data from a U.S. study with a single dose of a vaccine are expected in May, while results from studies on two-dose vaccine regimens are expected in June, the USDA said.
If the trials are su...
By Andrew Chung
WASHINGTON - Danco Laboratories, the manufacturer of the abortion pill mifepristone, on Friday asked the U.S. Supreme Court to block limits set by lower courts on access to the drug in a challenge by anti-abortion groups.
Danco filed an emergency request asking the justices to put on hold a ruling by U.S. District Judge Matthew Kacsmaryk in Texas to significantly restrict the pill's distribution while litigation in the challenge proceeds. U.S. Attorney General Merrick Garland said on Thursday that President Joe Biden's administration also will seek emergency relief from the high court as the federal government moves to defend access to the mifepristone.
Curbing access to mifepristone would deal another major setback to U.S. abortion rights on the national level after the Supreme Court in June 2022 overturned the landmark 1973 Roe v. Wade decision that had legalized the procedure across the country. The Supreme Court has a...
THE HAGUE - The Netherlands will widen its existing euthanasia regulations to include the possibility of doctor-assisted death for terminally ill children between one and twelve years old, the Dutch government said on Friday.
The new rules would apply to an estimated group of around 5 to 10 children per year, who suffer unbearably from their disease, have no hope of improvement and for whom palliative care cannot bring relief, the government said.
"The end of life for this group is the only reasonable alternative to the child's unbearable and hopeless suffering," it said in a statement.
In 2002, the Netherlands was the first country in the world to legalise euthanasia under strict conditions. All cases of euthanasia must be reported to medical review boards.
The law already provided possibilities for euthanasia involving terminally ill babies until their first birthday and for children aged older than 12.
- Contract drug manufacturer Catalent Inc on Friday warned that low production at three of its facilities and higher costs would impact its fiscal 2023 results and said its CFO Thomas Castellano has stepped down, sending its shares down 20%.
The company's clients have included COVID-19 vaccine makers such as Moderna Inc and Johnson & Johnson.
Catalent said it experienced "productivity issues" at its gene therapy manufacturing site in Harmans, Maryland, and faced similar issues at its drug product and drug substance manufacturing facilities in Bloomington, Indiana and Brussels, Belgium.
The issues would impact financial results for the third quarter and Catalent's forecast for the remainder of fiscal 2023, the company said.
Catalent named company insider Ricky Hopson as interim CFO and said it had launched the search for a permanent finance chief.
The company's shares were trading at $50.77 before the bell....
- Florida's Republican Governor Ron DeSantis has signed a bill into law that bans most abortions after six weeks, setting the stage for abortion access to be drastically curtailed in the state and across the U.S. South.
DeSantis signed the legislation late on Thursday night after lawmakers in the state's Republican-led House of Representatives approved it with a 70-40 vote. The bill passed the state Senate by a vote of 26-13 on April 3.
"We are proud to support life and family in the state of Florida," DeSantis said in a statement.
The legislation makes exceptions for abortions in cases of rape, incest and when the mother's life or health are at serious risk.
Backing more severe restrictions could carry political risks for DeSantis, who is expected to seek the Republican nomination for president in 2024.
Abortion has emerged as a potent political issue in the U.S. since the Supreme Court overturned Roe v. Wad...
LONDON - There is no evidence as yet that proves the COVID-causing virus came from animals, George Gao, former head of the Chinese Center for Disease Control and Prevention (CDC) said on Friday.
Gao, who was speaking at a London summit on preparing for pandemics, was the head of the agency when COVID first emerged in Wuhan, China at the end of 2019.
“Even now, people think some animals are the host or reservoir,” said Gao. “Cut a long story short, there is no evidence which animals [were] where the virus comes [from].”
(Reporting by Jennifer Rigby in London, additional reporting by Natalie Grover in London; Editing by Toby Chopra)...
- UnitedHealth Group Inc's quarterly profit beat Wall Street estimates on Friday, as a slow recovery in non-urgent procedures helped lower medical costs at its insurance unit.
Excluding items, the company reported a profit of $6.26 per share for the first quarter, beating analysts' average estimate of $6.13 per share, according to Refinitiv IBES data.
(Reporting by Khushi Mandowara and Bhanvi Satija in Bengaluru; Editing by Devika Syamnath)...
AMSTERDAM - Philips clarified on Friday that 2.2 million devices it has repaired or replaced in a major recall of respiratory devices are actually in the hands of patients in the United States.
The Dutch healthcare equipment maker issued a statement clarifying progress of the recall program underway since 2021after the FDA issued a statement on April 13 saying that the number of devices the company had replaced was "considerably less" than the 2.46 million indicated on the company's website.
Philips shares were down 2.7% at 16.32 euros at 0842 GMT in Amsterdam.
(Reporting by Toby Sterling; Editing by Toby Chopra)...
- The U.S. Food and Drug Administration (FDA) has declined approval for Eli Lilly and Co's drug to treat a type of chronic inflammatory bowel disease in adults, the company said on Thursday.
The health regulator cited issues related to the proposed manufacturing of the drug, mirikizumab, with no concerns about the clinical data package, safety, or label for the medicine.
The company said it was confident in the drug's late-stage data and was working with the FDA.
(Reporting by Raghav Mahobe, Bhanvi Satija and Sriparna Roy in Bengaluru; Editing by Rashmi Aich and Anil D'Silva)...