Market Place
This week’s pharma news capsule – Phispers (Pharmaceutical Whispers) – updates us on smoking cessation pills, WHO alert on Bangalore’s Semler Research, Valeant’s new CEO and more.Novartis plans to
sell Roche stake and fuel its M&A machine Novartis
is in
talks with banks to sell its US $ 14 billion stake in rival Roche.
Once struck, the sale will provide the Basel-headquartered Novartis cash for
new deals. Between 2001 and 2003, Novartis had built up its one-third stake in
Roche's voting stock under former chairman and CEO Daniel Vasella, as a basis
for a possible merger that never happened. Since Vasella's departure in 2013, there
has been speculation that Novartis would sell its holding. The divestment makes sense for current Novartis CEO Joe Jimenez, who is under pressure to improve growth after disappointments with the company’s eye care unit Alcon
and new heart drug Entresto. After FDA action, WHO
issues notice of concern to Bangalore-based CRO Semler Just days after the FDA alerted an
untold number of drug makers that marketing applications containing clinical
trial data prepared by Semler Research Center would have to be repeated, due to
data integrity concerns, the World Health Organization (WHO) issued the company
a notice
of concern. Investigators concluded that, “Manipulation of at least five studies over an extended period of time indicates this is a common practice; WHO is of the impression that to execute this type of manipulation several staff members on various levels within the organization have to be collaborating and coordinating.”The findings have questioned studies performed on WHO
pre-qualified products for Mylan
Laboratories, Micro Labs
Ltd, Lupin
Ltd, Strides Shasun Ltd as well as others which are currently under evaluation. Valent ropes in Perrigo’s Joseph Papa to be its next CEOValeant
Pharmaceuticals International has taken on Joseph
Papa (aged 60) from its rival Dublin-based Perrigo to be its chairman and chief executive and work on rebuilding investor confidence in Valeant, after last year’s price-gouging episodes and the more recent accounting troubles. The announcement came after weeks of talks with Papa. The
news led to tumbling of Perrigo shares
by 18 percent on Monday. Some months back,
Papa had helped Perrigo beat
back a hostile bid from Mylan. Nonetheless,
Papa leaves behind a business which is struggling business to meet the
commitments made while fending off the Mylan bid. Setback for DMD patients as FDA panel votes against Sarepta’s drugOn Monday, the FDA advisory panel in the US voted that a
drug from Sarepta Therapeutics was not effective in treating Duchenne muscular dystrophy (DMD) – a rare and fatal muscle-wasting disease. While the FDA staff took dim view of the Sarepta trial data,
the day-long session saw emotional pleas from dozens of parents and their
children, some of whom appeared in wheelchairs, to describe how the Sarepta
drug, called eteplirsen, could impact their lives. While the FDA usually follows the advisory panel’s recommendation, the final decision on whether or not to approve eteplirsen will be taken on May 26. Smoking-cessation
pills have no suicide risk, says studySeven years after American regulators slapped the strictest ‘black box’ warnings on two popular smoking-cessation medicines – Pfizer’s Chantix and GlaxoSmithKline’s Zyban – a large international study found these pills did
not appear to increase the risk of suicidal behavior. The study had been order by the US Food and Drug Administration (FDA), and both Pfizer and GSK are hopeful that the regulator will remove warnings put on these prescription drugs. The warnings about serious psychiatric side effects, such as “changes in behavior, hostility, agitation, depressed mood, and suicidal thoughts or actions” in some patients scared off both doctors and smokers wanting to quit. Meanwhile, experts say both Chantix and Zyban are safe — far safer than smoking, which kills about 440,000 Americans each year. Drug makers may lose
case in the US over patent reviewsA case in the US could end up with serious implications for drug pricing. In the Supreme Court this week, there were signs that the pharmaceutical industry could end up on the losing side of the case – which focuses on Obama administration’s rules for a new
process to review patents.Drug makers, supporting the plaintiffs, are urging the court
to change that process, which at present makes it easier to invalidate the
patents that are crucial to their business. But the plaintiffs seemed to be at
a disadvantage before the court.
Impressions: 2569
https://www.pharmacompass.com/radio-compass-blog/phispers-novartis-may-sell-roche-stake-perrigo-s-ceo-to-head-valeant
#PharmaFlow by PHARMACOMPASS
28 Apr 2016
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Beginning
this week, PharmaCompass introduces this new column on the week’s headlines in the world of pharmaceuticals. Get the buzz on what to expect in the days to come. Though we are only a few weeks into 2016, we notice that compliance and safety problems are continuing to dominate headlines.
Mylan finally
acquires Meda for US $ 7.2 billion
The week’s biggest news has been the acquisition of Swedish-firm Meda AB by Pennsylvania-headquartered Mylan NV for about US $ 7.2billion. Meda will strengthen Mylan’s specialty drug products and European operations. The acquisition also marks one of the highest premiums ever paid in a pharma deal worth US $ 5 billion of more. The deal comes after two offers made by Mylan to acquire Meda in 2014 were rejected by the latter. Last year, Mylan also failed in its attempt to acquire Perrigo Co, a manufacturer of over-the-counter (OTC) drugs.
“Systemic data manipulation” uncovered by FDA at Ipca
Three
Ipca sites have been on FDA’s import alert list for almost a year. Last week, FDA’s warning letter to India’s Ipca Laboratories became available for review. The FDA inspections were done in 2014. The most striking aspect of the letter is Ipca’s “systemic data manipulation”. The letter says data manipulation practices are commonplace at Ipca’s analytical laboratory. During the inspection, FDA investigators spoke to an analyst who reported that “…if we find a failure, we set back the date/time setting and re-integrate to achieve passing results…” The analyst explained such
manipulation was done for raw materials, in-process testing, and finished API
drugs. Barbara Unger’s blog
shares a summary of the deceptive practices of
data manipulation “that
were known to and supported by the management”.
Ind-Swift maybe
next to hit the regulatory wall
India’s Ind-Swift Laboratories seems the next
company to run into compliance trouble as Health Canada’s inspection tracker has listed data integrity concerns uncovered by “a trusted regulatory partner”. The tracker provides a snapshot of the potential health and safety issues Health Canada is tracking “with companies that fabricate, package/label, test, wholesale, distribute or import drugs for sale in Canada”. Our previous experience indicates that it is just a matter of time before Ind-Swift is either on the FDA’s or on a European regulatory scanner.
Taizhou Xinyou
on FDA import alert list
Taizhou Xinyou Pharmaceutical and Chemical in Zhejiang district of China manufactures APIs for repackagers and distributors, some of which sell these products to compounding facilities in the US. When the FDA contacted Taizhou through its agent in the US, the company confirmed that the baclofen API it manufactures is not suitable for use in injectable drugs. In December 2015, the USFDA warned drug compounders about the risk of using baclofen
API from Taizhou. And this month, Taizhou has made it to the FDA import
alert list
for refusing to accept an FDA inspection.
42 deficiencies
uncovered at Svenska Bioforce in Sweden
It’s not just drug manufacturers from China and India that are slackening control on good manufacturing practices (GMP). Sweden-based Svenska Bioforce AB had 42 deficiencies uncovered during a GMP inspection
which failed to convince inspectors that the company’s Pharmaceutical Quality System meets the EU-GMP requirements.
FDA seeks US $
5.1 billion budget for food safety
The
US Food and Drug Administration has requested a
total budget of US $ 5.1 billion to protect and promote public health as part of the President’s budget for the 2017 fiscal year. This is an 8 percent increase over the budget enacted for the 2016 fiscal year. The budget would be used to implement
food safety law, improve medical
product safety and quality. The agency is also seeking US $ 75 million in new
mandatory funding to support the National Cancer Moonshot initiative led by the
Vice President.
India protects
domestic drug-makers by lifting customs exemptions
Last week, the Indian government withdrew custom exemptions on 74 drugs, including lifesaving ones used to treat cancer and HIV. The move is intended to provide protection to domestic manufacturers and enhance the attractiveness of the ‘Make in India’ initiative, analysts said. As a result, several drugs may see a spurt in prices. The list includes medicines used to treat kidney stones, cancer chemotherapy and radiotherapy, life-threatening heart rhythm disorders, diabetes, Parkinson's disease, bone diseases, antibiotic to treat infections, drugs used for bacterial infections, leukemia, anesthetic medication, HIV or hepatitis B virus cells, allergies, arthritis, lupus and ulcerative colitis.
Concerns raised over Entresto’s alarmist advertisement
Novartis’ new heart failure drug Entresto is expected to generate US $ 5 billion in peak sales. However, Novartis’ advertising campaign used to sell Entresto and cash in on its potential has been called “alarmist,” “terrifying” and “shameful” by CardioBrief. The ad depicts a middle-aged man in an easy
chair reading the newspaper, oblivious to a rising flood that threatens to
drown him, though his dog, climbing onto a couch for safety, expresses
considerable anxiety.
Scientists figure out why hair thins with age
If hair loss has concerned you, Stat News covered the progress scientists have made to understand why our hair thins as we age. According to this report, two new studies point at the scalp’s constantly-renewing stem cells. Mutations in these cells appear to make hair follicles shrink, causing regular hair to be replaced by thin wisps. Understanding the genes at work in this process may allow scientists a way to prevent such hair loss. While a treatment is still not on the horizon, the path of progress has never followed a straight path.
Explosion at a
drug intermediate plant in Hyderabad kills six
An explosion at a company based in Hyderabad that makes drug intermediates killed six people. According to a report “a nutsche filter attached to a reactor exploded, killing those standing close to it.” The unit is owned by Hasita Aromatics Private Ltd, a small-scale company based in Hyderabad. There are dozens of chemical factories operating in the industrial estates located around Hyderabad. And several such incidents have occurred in the past, in this region.
Impressions: 2244
https://www.pharmacompass.com/radio-compass-blog/pharmacompass-weekly-recap-compliance-and-safety-snags-dominate-deadlines
#PharmaFlow by PHARMACOMPASS
10 Feb 2016
