President Donald Trump has called on pharmaceutical companies to lower huge drug prices.
During a White House meeting with senior pharmaceutical executives President Trump told the companies to manufacture more of their drugs in the US.
However, the president also vowed to help the companies by speeding the approval of new medicines and by cutting taxes.
Donald Trump’s pledges helped to send shares in many of the biggest US drugmakers higher on January 31.
Pharmaceutical companies have faced intense criticism from US politicians – including Donald Trump – as well as insurance companies and patients’ groups over the high cost of new medicines and price hikes in some older generic drugs.
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Among those attending the meeting were executives from Merck, Johnson & Johnson, Novartis, Amgen and the head of the Pharmaceutical Research and Manufacturers of America (PhRMA) lobbying group.
Donald Trump told them in the meeting: “US drug companies have produced extraordinary results for our country but the pricing has been astronomical for our country, we have to do better.
“We have to get even better innovation, and I want you to move your companies back to the United States.”
To help the drugmakers, Donald Trump said his administration was “going to be lowering taxes big league”.
“We’re going to be getting rid of regulations that are unnecessary – big league,” he added.
Donald Trump’s promise to speed up approvals by the FDA for new medicines sparked strong gains in pharmaceutical shares.
Shares in Merck and Amgen rose by about 1% while Novartis was up more than 2% on Wall Street.
The NASDAQ Biotech Index gained nearly 3% after the meeting and the S&P 500 health care index rose 1.4%.
Investors had sold off shares in drugmakers in recent weeks following heavy criticism from Donald Trump – supported by Democratic Senator Bernie Sanders – over drug pricing.
However, senior pharmaceutical executives welcomed Donald Trump’s proposals on January 31 to cut taxes and loosen regulations.
Pharmaceutical giants Novartis and GlaxoSmithKline have agreed to exchange assets and combine their consumer healthcare units.
Novartis will acquire GSK’s oncology drugs business for $16 billion and sell its vaccines division, excluding the flu unit, to GSK for $7.1 billion.
In a separate deal, Novartis has agreed to sell its animal health division to Lilly for nearly $5.4 billion.
Novartis said the moves would help the company focus on its key businesses.
Novartis will acquire GSK’s oncology drugs business for $16 billion and sell its vaccines division, excluding the flu unit, to GSK for $7.1 billion
“The transactions mark a transformational moment for Novartis,” Novartis CEO Joseph Jimenez said in a statement.
“They also improve our financial strength, and are expected to add to our growth rates and margins immediately.”
The deals are a part of Novartis’s review of its business as it continues to face sluggish growth.
Novartis and GSK said that combining their over-the-counter (OTC) units would help boost the fortunes of both the companies.
The combined unit will have annual revenues of more than $10 billion.
“Opportunities to build greater scale and combine high quality assets in vaccines and consumer healthcare are scarce,” GSK CEO Andrew Witty said in a statement.
“With this transaction, we will substantially strengthen two of our core businesses and create significant new options to increase value for shareholders.”
Glaxo shareholders will get a $6.5 billion capital return from the deal proceeds, the company said.
Swiss drugmaker Novartis says it is investigating claims that its eye care unit, Alcon, bribed doctors in over 200 hospitals in China to promote its lens implants.
On Tuesday, a Chinese newspaper alleged that Alcon paid doctors “research fees” through a third-party for fake clinical trials that never took place.
This is the second such allegation to be made against Novartis recently.
Last month, the 21st Century Business Herald claimed Novartis bribed doctors to increase drug sales.
The latest report was also carried by the same paper.
Alcon allegedly bribed doctors in over 200 hospitals in China to promote its lens implants
“Alcon does not tolerate activities that are not in compliance with the laws and regulations in the markets where we operate,” Novartis said in a statement.
“When any inappropriate activities are identified, we take swift remedial action.”
Novartis is the latest pharmaceutical company to come under scrutiny in China.
Last month, the 21st Century Business Herald carried a report making bribery claims against US drugmaker Eli Lilly.
It cited a former employee of the firm, identified by a pseudonym, as saying the firm paid out 30 million yuan ($4.9 million) as bribes to doctors to prescribe its drugs.
Eli Lilly said it had launched an internal probe last year after a former manager made similar allegations against it. It said that while it had not been able to verify the allegations it was continuing to investigate them.
In July, Chinese authorities accused British drug giant GlaxoSmithKline (GSK) of bribing doctors to boost sales of some of its drugs in the country.
GSK is alleged to have directed up to $500 million through travel agencies to facilitate bribes to doctors and officials.
The company has admitted that some senior executives in its China office appear to have broken the law.
GSK has said that it is co-operating with the authorities.
India’s Supreme Court has rejected a plea by Swiss drugmaker Novartis to patent an updated version of its cancer drug, Glivec.
Novartis had been denied a patent by Indian authorities on the grounds that Glivec new version was only slightly different from the old.
There were concerns that a patent could threaten access to cheap generic versions of drugs in poorer countries.
India’s Supreme Court has rejected a plea by Swiss drugmaker Novartis to patent an updated version of its cancer drug, Glivec
But some Western companies had warned that a decision against Novartis could discourage investment in research.
Glivec, which is used to treat chronic myeloid leukaemia and other cancers, costs about $2,600 a month.
The generic equivalent is currently available in India for just $175.
“This will go a long way in providing affordable medicine for the poor,” said Anand Grover, a lawyer representing Cancer Patients Aid Association, adding that he was “ecstatic with the ruling”.
Novartis applied for a patent in 2006 for its new version of the drug, arguing that it was easier to absorb and therefore qualified for a fresh patent.
However, the Indian patent authority rejected the application based on a law aimed at preventing companies from getting fresh patents by making only minor changes to existing drugs, a practice known as “evergreening”.
Officials also turned down a subsequent appeal by the company three years later.
On Monday, India’s Supreme Court rejected Novartis appeal to get patent protection for the drug.
The AFP news agency quoted the court as saying that the updated drug “did not satisfy the test of novelty or inventiveness” as required by the law.
Patents usually protect the companies for 20 years of exclusive sales. After that, it is open to other firms who can make cheaper copies of the original drug.
Once the protection expires, the first company to challenge the patent gets an exclusive right to sell the copy for 180 days.
After 180 days, more companies can sell the generic versions, potentially resulting in a further price drop.
It is estimated that drugs with combined annual sales of $150 billion will go off-patent by 2015.
India’s generic drug makers are among the biggest in the world and many expect them to benefit from these patents expiring in the coming years.
However, there have been concerns that if firms are granted patents for updated versions of their drugs, it may not only deny access to cheaper medicines to poor people, but also hurt the makers of generic drugs.
Pratibha Singh, a lawyer for the Indian generic drug manufacturer Cipla, said the ruling had set a precedent that would prevent international pharmaceutical companies from obtaining fresh patents in India on updated versions of existing drugs.
“Patents will be given only for genuine inventions, and repetitive patents will not be given for minor tweaks to an existing drug,” she said.
Shares of Novartis India fell almost 5% on the Bombay Stock Exchange, while stocks of generic drugmakers such as Cipla and Natco rose after the judgement.
FDA is warning patients about a potential mix-up between powerful prescription pain drugs and common OTC medications like Excedrin and Gas-X manufactured by Swiss drug maker Novartis.
The issue is a result of major manufacturing problems at a Lincoln, Nebraska, facility which was shut down last month because of the issues.
Novartis has recalled bottles of Excedrin, Bufferin, Gas-X and NoDoz which may have included mixed up pills.
Now the Food and Drug Administration says some of those OTC pills may have accidentally been packaged with powerful prescription painkillers made at the same facility.
The opioid drugs are sold by Endo Pharmaceuticals as Percocet, Endocet, Opana and Zydone.
FDA officials say they are not recalling the prescription drugs because they are medically necessary and the likelihood that they contain stray pills is low.
FDA’s Dr. Edward Cox told reporters:
“The likelihood of finding a wrong tablet in an opiate pain medication dispensed to patients is low and patients should not be unduly alarmed.”
Novartis said it has voluntarily suspended operations and shipments from its Lincoln, Nebraska, facility to rectify the problems at the site.
The plant has been under fire from inspectors from FDA for its quality control. An FDA report said the company did not properly address any of the 223 critical complaints it received in 2011.
In 2010, the plant did not rectify 165 of the 587 complaints it got, according to the FDA.
Additionally, the company failed to investigate 166 reports of pills being packaged in the wrong bottles in 2009.
The Journal Star newspaper in Lincoln reported that the FDA blamed the problems on Novartis having too few people at the plant to review complaints. The staffers the company does have are poorly trained, the FDA, added.
Novartis said it is working to upgrade and improve manufacturing and training at the Nebraska plant before restarting production.
Company officials have said they don’t know exactly how many bottles will be affected by the recall or when the factory will come back online.
Spokeswoman Julie Masow said there is no indication prescription pills actually got mixed up with Novaris OTC drugs, but the recalls are a precaution.
Novartis said its Consumer Health unit will take a one-time charge currently estimated at $120 million in the fourth quarter relating to the recalls and improvements at the facility.
The company said it implemented the recall, which affects U.S. retailers, voluntarily and is working with FDA during the process.
It became aware of the potential problem during an internal review that identified broken and chipped pills, and inconsistent bottle packaging that could cause pills to be mixed up.
Novartis said it wanted to make sure that customers didn’t take any pills that they might be allergic to or that might become dangerous when mixed with their other medications, though it also said that there have been no such reports from consumers.
The drug maker said that some of the bottles of headache medicine Excedrin and caffeine caplets NoDoz with expiration dates of December 20, 2014, or earlier will be subject to the recall.
Some of the packages of pain medicine Bufferin and stomach medicine Gas-X with expiration dates of December 20, 2013, or earlier will also be affected.
The company said it will post more information Monday at www.novartisOTC.com. Customers can also call the company at 1-888-477-2403 Monday to Friday, 9:00 a.m. to 8:00 p.m. EST.
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