Market Place
Acquisitions and spin-offs dominated headlines in 2019 and the tone was set very early with Bristol-Myers Squibb acquiring
New Jersey-based cancer drug company Celgene in a US$ 74 billion deal announced on
January 3, 2019. After factoring
in debt, the deal value ballooned to about US$ 95 billion, which according
to data compiled by Refinitiv, made it the largest healthcare deal on
record.
In the summer, AbbVie Inc,
which sells the world’s best-selling drug Humira, announced its acquisition of Allergan Plc, known for Botox and other cosmetic
treatments, for US$ 63 billion. While the companies are still awaiting
regulatory approval for their deal, with US$ 49 billion in combined 2019
revenues, the merged entity would rank amongst the biggest in the industry.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
The big five by pharmaceutical sales — Pfizer,
Roche, J&J, Novartis and Merck
Pfizer
continued
to lead companies by pharmaceutical sales by reporting annual 2019 revenues of
US$ 51.8 billion, a decrease of US$ 1.9 billion, or 4 percent, compared to
2018. The decline was primarily attributed to the loss of exclusivity of Lyrica in 2019,
which witnessed its sales drop from US$ 5 billion in 2018 to US$ 3.3 billion in
2019.
In 2018, Pfizer’s then incoming CEO Albert Bourla had mentioned that the company did not see the need for any large-scale M&A activity as Pfizer had “the best pipeline” in its history, which needed the company to focus on deploying its capital to keep its pipeline flowing and execute on its drug launches.
Bourla stayed true to his word and barring the acquisition of Array Biopharma for US$ 11.4 billion and a spin-off to merge Upjohn, Pfizer’s off-patent branded and generic established medicines business with
Mylan, there weren’t any other big ticket deals which were announced.
The
Upjohn-Mylan merged entity will be called Viatris and is expected to have 2020
revenues between US$ 19 and US$ 20 billion
and could outpace Teva to
become the largest generic company in the world, in term of revenues.
Novartis, which had
followed Pfizer with the second largest revenues in the pharmaceutical industry
in 2018, reported its first full year earnings after spinning off its Alcon eye
care devices business division that
had US$ 7.15 billion in 2018 sales.
In 2019,
Novartis slipped two spots in the ranking after reporting total sales of US$
47.4 billion and its CEO Vas Narasimhan continued his deal-making spree by buying New
Jersey-headquartered The Medicines Company (MedCo) for US$ 9.7
billion to acquire a late-stage cholesterol-lowering
therapy named inclisiran.
As Takeda Pharmaceutical Co was
busy in 2019 on working to reduce its debt burden incurred due to its US$ 62
billion purchase of Shire Plc, which was announced in 2018, Novartis also purchased
the eye-disease medicine, Xiidra, from the Japanese drugmaker for US$ 5.3 billion.
Novartis’ management also spent a considerable part of 2019 dealing with data-integrity concerns which emerged from its 2018 buyout of AveXis, the
gene-therapy maker Novartis had acquired for US$ 8.7 billion.
The deal gave Novartis rights to Zolgensma,
a novel treatment intended for children less than two years of age with the
most severe form of spinal muscular atrophy (SMA). Priced at US$ 2.1 million,
Zolgensma is currently the world’s most expensive drug.
However,
in a shocking announcement, a month after approving the drug, the US Food and
Drug Administration (FDA) issued a press release on
data accuracy issues as the agency was informed by AveXis that
its personnel had manipulated data which
the FDA used to evaluate product comparability and nonclinical (animal)
pharmacology as part of the biologics license application (BLA), which was
submitted and reviewed by the FDA.
With US$
50.0 billion (CHF 48.5 billion) in annual pharmaceutical sales, Swiss drugmaker
Roche came in at number two position in 2019
as its sales grew 11 percent driven by
its multiple sclerosis medicine Ocrevus, haemophilia drug Hemlibra and cancer medicines Tecentriq and Perjeta.
Roche’s newly introduced medicines generated US$ 5.53 billion (CHF 5.4 billion) in growth, helping offset the impact of the competition from biosimilars for its three best-selling drugs MabThera/Rituxan, Herceptin and Avastin.
In late 2019, after months of increased
antitrust scrutiny, Roche completed
its US$ 5.1 billion acquisition of Spark Therapeutics to strengthen its presence in
gene therapy.
Last year, J&J reported almost flat worldwide sales of US$ 82.1 billion. J&J’s pharmaceutical division generated US$ 42.20 billion and its medical devices and consumer health divisions brought in US$ 25.96 billion and US$ 13.89 billion respectively.
Since J&J’s consumer health division sells analgesics, digestive health along with beauty and oral care products, the US$ 5.43 billion in consumer health sales from over-the-counter drugs and women’s health products was only used in our assessment of J&J’s total pharmaceutical revenues. With combined pharmaceutical sales of US$ 47.63 billion, J&J made it to number three on our list.
While the sales of products like Stelara, Darzalex, Imbruvica, Invega Sustenna drove J&J’s pharmaceutical business to grow by 4 percent over 2018, the firm had to contend with generic competition against key revenue contributors Remicade and Zytiga.
US-headquartered Merck, which is known as
MSD (short for Merck Sharp & Dohme) outside the United States and
Canada, is set to significantly move up the rankings next year fueled by its
cancer drug Keytruda, which witnessed a 55
percent increase in sales to US$ 11.1 billion.
Merck reported total revenues of US$ 41.75 billion and also
announced it will spin off its women’s health drugs,
biosimilar drugs and older products to create a new pharmaceutical
company with US$ 6.5 billion in annual revenues.
The firm had anticipated 2020 sales between US$ 48.8 billion and US$ 50.3 billion however this week it announced that the coronavirus pandemic will reduce 2020 sales by more than $2 billion.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Humira holds on to remain world’s best-selling drug
AbbVie’s acquisition of Allergan comes as the firm faces the expiration of patent protection for Humira, which brought in a staggering US$ 19.2 billion in sales last year for
the company. AbbVie has failed to successfully acquire or develop a major new
product to replace the sales generated by its flagship drug.
In 2019, Humira’s US revenues increased 8.6 percent to US$ 14.86 billion while internationally, due
to biosimilar competition, the sales dropped 31.1 percent to US$ 4.30 billion.
Bristol Myers Squibb’s Eliquis, which is also marketed by Pfizer, maintained its number two position
and posted total sales of US$ 12.1 billion, a 23 percent increase over 2018.
While Bristol Myers Squibb’s immunotherapy treatment Opdivo, sold in partnership with Ono in Japan, saw sales increase from US$ 7.57 billion to US$ 8.0 billion, the growth paled in comparison to the US$ 3.9
billion revenue increase of Opdivo’s key immunotherapy competitor Merck’s Keytruda.
Keytruda took the number three spot in drug sales that
previously belonged to Celgene’s Revlimid, which witnessed a sales decline from US$ 9.69 billion to US$ 9.4 billion.
Cancer treatment Imbruvica, which is marketed
by J&J and AbbVie, witnessed a 30 percent increase in sales. With US$ 8.1
billion in 2019 revenues, it took the number five position.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Vaccines – Covid-19 turns competitors into partners
This year has been dominated by the single biggest health emergency in years — the novel coronavirus (Covid-19) pandemic. As drugs continue to fail to meet expectations, vaccine development has received a lot of attention.
GSK reported the highest vaccine sales of all drugmakers with
total sales of US$ 8.4 billion (GBP 7.16 billion), a significant portion of its
total sales of US$ 41.8 billion (GBP 33.754 billion).
US-based Merck’s vaccine division also reported a significant increase in sales to US$ 8.0 billion and in 2019 received FDA and EU approval to market its Ebola vaccine Ervebo.
This is the first FDA-authorized vaccine against the deadly virus which causes
hemorrhagic fever and spreads from person to person through direct contact with
body fluids.
Pfizer and Sanofi also reported an increase in their vaccine sales to US$ 6.4
billion and US$ 6.2 billion respectively and the Covid-19 pandemic has recently
pushed drugmakers to move faster than ever before and has also converted
competitors into partners.
In a rare move, drug behemoths — Sanofi and GlaxoSmithKline (GSK) —joined hands to develop a vaccine for the novel coronavirus.
The two companies plan to start human trials
in the second half of this year, and if things go right, they will file
for potential approvals by the second half of 2021.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Our view
Covid-19 has brought the world economy to a grinding halt and shifted the global attention to the pharmaceutical industry’s capability to deliver solutions to address this pandemic.
Our compilation shows that vaccines and drugs
for infectious diseases currently form a tiny fraction of the total sales of
pharmaceutical companies and few drugs against infectious diseases rank high on
the sales list.
This could well explain the limited range of
options currently available to fight Covid-19. With the pandemic currently infecting
over 3 million people spread across more than 200 countries, we can safely
conclude that the scenario in 2020 will change substantially. And so should our
compilation of top drugs for the year.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Impressions: 54757
https://www.pharmacompass.com/radio-compass-blog/top-drugs-and-pharmaceutical-companies-of-2019-by-revenues
#PharmaFlow by PHARMACOMPASS
29 Apr 2020
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This week, Phispers takes you through the EpiPen price hike controversy, and the Indian government’s decision not to adopt a bulk drug policy. There is more news pertaining to Teva’s divestitures, GSK’s new drug for HIV treatment and drug recalls by Cadila, Teva and Sagent. A setback to Indian pharma as minister
says govt against bulk drug policy Earlier this year PharmaCompass had highlighted the ‘inconvenient
truth about Chinese drug manufacturing’ – that a serious imbalance exists in the global supply chain with regard to its dependence on China. India had declared 2015 as the Year of the API, under the ‘Make in India ‘programme. A Cabinet note for a bulk drug policy, based on the recommendations of the Katoch committee, had been floated
earlier this year. Such a policy would have helped the Indian
pharmaceutical sector turn into a US $ 200-billion industry by 2030, and
shifted global dependence away from China.However, the plan suffered a setback as the chemical and fertiliser minister Ananth Kumar announced this week that
the government was against
a bulk drug policy. Instead, states will have to come up with “bulk drug parks” which will help boost manufacturing of bulk drugs.This news comes at a time when a Bloomberg
analysis concluded that China
drug sales grow despite safety concerns at home. Around 700 Chinese firms were told by regulators in China to review their pending applications to sell new drugs and voluntarily withdraw those that were false or incomplete. “Within months, about 75 percent had been retracted by the manufacturers or rejected by Chinese officials,” the Bloomberg report said.Currently, India is dependent on China for APIs. More than 75 per cent of India’s bulk drug imports come from China. And there is concern over quality. Mylan CEO blames system for EpiPen price hike,
announces launch of generic versionLast week, Mylan made headlines as its 400 percent price increase of EpiPen auto-injector came under scrutiny. The furor continued,
even as the Mylan CEO Heather Bresch tried her best to justify the price hikes
in an interview, which generated more negative publicity. In the interview, Bresch blamed the healthcare system for the price hike. According to her, the price of US $ 608 for the life-saving EpiPen reflects a system where there are “four or five hands that the product touches and companies that it goes through before it ever gets to that patient at the counter.” This week, Mylan tried to suppress the furor by
announcing it would launch an authorized generic version of EpiPen for half the price of the brand-name product. The identical generic two-pack of EpiPens, expected to launch in several weeks, will have a list price of US $ 300. This is still significantly higher than the price of the auto-injector prior to Mylan’s acquisition of the EpiPen in 2007. In Canada, the twin pack costs US $ 200, in France it is around US $ 100.In the interview, Bresch acknowledged that the high
retail price in the US was used to subsidize the price of EpiPens in Europe, where
they sold at just US $ 100 or US $ 150.Bresch went onto say: “Congress and the leaders of this country need to quit putting their toe in this topic and really fix this — we have an outdated system.”After the interview, pharma bad boy Martin Shkreli defended the price increase while some Americans turned to Canada for cheaper EpiPens. And Senators questioned if the FDA was to blame for the high drug prices. Meanwhile, analysts said the authorized generic
version of EpiPen may actually make more money for Mylan! Aurobindo, Intas in race to buyout UK and Irish
portfolios of TevaLast week, two Indian drug makers – Aurobindo Pharma and Intas Pharmaceuticals – emerged as the final contenders to buyout the UK and Irish portfolios of Teva. These portfolios of the Israeli generics behemoth have been put up for
sale to comply with the European anti-trust regulations.Both Aurobindo and Intas put
up binding offers of around US $ 1 billion, along with firm financing
commitments, The Economic Times
reported. Last year, Teva had acquired
Allergan Plc’s generic business for US $ 40.5 billion. Teva
is selling assets as part of a broader divestiture process to comply with the
anti-trust regulations for this acquisition.In order to comply with
these regulations, Teva has already sold 80 products in the US to drug makers
like Dr Reddy’s, Sagent, Cipla, Zydus Cadila, Aurobindo, Impax and Perrigo. Glaxo plans to shake up HIV treatment with new drugGlaxoSmithKline plans to capsize the decade-old strategy for treating HIV. Executives at GSK are hoping that the company’s latest HIV pill is powerful enough to suppress the virus, with the help of just one more drug. The drug – Dolutegravir – belongs to a class of HIV drugs known as integrase inhibitors that rapidly reduces the level of virus in the blood. It has already been approved for use as part of traditional triple therapy and hasn’t reported cases of the virus developing resistance to dolutegravir in patients who are new to the treatment.Since the mid-1990s, the treatment of HIV – a virus that causes AIDS – hasn’t changed much. In the mid-1990s, a new class of antiretroviral drugs were introduced. One drug from the new class, along with two other drugs from an earlier class, hindered the virus from developing resistance. This three-drug regimen has been the standard approach for treating HIV for the last two decades.Dolutegravir, according to GSK CEO Andrew Witty, would
be the game changer because taking fewer drugs will lead to fewer side effects.GSK’s majority-owned HIV business – ViiV Healthcare – is undergoing the long process of proving the efficacy of the Dolutegravir. Pfizer and Japan’s Shionogi & Co hold minority shares
in ViiV Healthcare. Japanese wholesaler arrested for illegally selling drugs to Chinese
touristsHidenobu Zaima, president of Tokyo-based drug wholesaler – Biken Pharmacy, was arrested along with four others, on the suspicion of illegally selling
large quantities of prescription drugs to Chinese tourists and violating the
Pharmaceutical and Medical Device Law.Zaima is believed to have sold about 291,000 products
to a Chinese broker for US $ 147,000 between September 2015 and May 2016. Chinese tourists often buy prescription and
over-the-counter products in other countries, such as Japan and Hong Kong,
where they can be cheaper. They also believe that drugs bought in these
countries would be of better quality. Teva, Cadila and Sagent recall drugsThis was a week of drug recalls in the US. Teva issued
a recall of antibiotics for the second time
this year. This time the recall pertained to amoxicillin manufactured at a plant in Canada. The
company is recalling 53,000 bottles of the drug manufactured by Teva Canada Limited in Toronto.Earlier this year, Teva had recalled amikacin sulfate manufactured at its
facility in Hungary due to the potential for the presence of glass particulate.
Meanwhile, India’s Cadila Healthcare recalled 26 batches (or 223,776 bottles)
of an antidepressant -- venlafaxine HCL ER capsules – as well as nine lots for which the company did not specify the bottle count. These drugs were manufactured at the company’s plant in Ahmedabad. The drugs failed dissolution specifications when retained samples were tested. Venlafaxine is used to treat major depressive disorder, anxiety and panic disorder.Similarly,
Sagent Pharmaceuticals recalled one lot of oxacillin for injection manufactured by India-based Astral SteriTech. The action was taken after a customer
complained that small, dark particulate matter was found in the solution after
it was reconstituted. The foreign matter found in the vials was identified as iron oxide.
Impressions: 3808
https://www.pharmacompass.com/radio-compass-blog/mylan-s-epipen-price-hike-defense-india-throws-out-plans-of-a-bulk-drug-policy
#PharmaFlow by PHARMACOMPASS
01 Sep 2016
Teva Pharmaceutical Industries, Ltd., which acquired Cephalon in 2012, will make a total payment of $1.2 billion as part of a ‘pay-for-delay’ settlement reached with the Federal Trade Commission (FTC) last week.
What exactly did Cephalon, for which Teva paid $6.8 billion, do so wrong? Isn’t ‘pay-for-delay’ common practice in the pharmaceutical industry?
First of all what is a
pay-for-delay?
‘Pay for delay’ or reverse payment patent settlements, are agreements where the brand name drug manufacturer compensates generics, not to market the generic product for a specific period of time.
These settlements allow the brand manufacturers to extend their
patent monopolies and according to an FTC study, these deals
cost consumers and taxpayers $3.5 billion in higher drug costs every year.
What exactly happens and
why is it a big deal now?
Cephalon allegedly paid four generic drug companies (Teva, Ranbaxy Pharmaceuticals, Mylan Pharmaceuticals, and Barr Laboratories), over $300 million in total. In return the generics agreed to drop their patent challenges and forgo marketing of their generic versions of Cephalon’s blockbuster sleep-disorder drug Provigil, for six years, until April 2012.
An extended monopoly for Provigil, in the absence of generic competition, was “$4 billion in sales that no one expected”, the CEO of Cephalon reportedly said when the deal was struck.
While in Europe, regulators have been going after pay-for-delay cases for years, it was only as recently as 2013, in FTC v. Actavis, that the U.S. Supreme Court made clear that reverse payment patent settlements are subject to the same antitrust rules that govern general U.S. business conduct.
The payment made by Teva will compensate purchasers, including drug wholesalers, pharmacies, and insurers, who overpaid because of Cephalon’s illegal conduct, is the first positive outcome for the FTC after the Supreme Court ruling.
How common are ‘pay-for-delay’ settlements?
Based on data provided by the FTC, for the past few years, more
than 100 settlements are reached annually between brand and generic
pharmaceutical companies.
Over 30% of these settlements have the potential of being ‘pay-for-delay’ agreements.
Table// Potential
pay-for-delay settlements reached between brand and generic companies:
Financial Year
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
Final Settlements:
between brand and generic companies
14
11
28
33
66
68
113
156
140
145
Involving First Generic Filing
8
5
11
16
29
32
49
54
43
41
Potential Pay-for-Delay:
Involving First Generic Filing
2
9
11
13
15
26
18
23
13
Settlements
3
14
14
16
19
31
28
40
29
How severe are the penalties for ‘pay-for-delay’ settlements in Europe?
The European Commission has
fined Johnson
& Johnson (J&J) just under 10.8 million
euros and Novartis 5.49 million euros, after discovering a ‘pay-for-delay’ deal on the painkiller Duragesic (fentanyl).
The amount pales in comparison to
the whopping €428m fine on Servier and several other companies (Niche/ Unichem; Matrix, which is now part of Mylan; Teva; Krka and Lupin) for conspiring to delay generics of the widely-used blood pressure drug Coversyl/ Aceon (perindopril).
In yet another settlement, agreements which operated in 2002 and
2003 between the Danish originator Lundbeck, and other
generic companies, resulted in Euro
146 million in fines.
What should we expect in the future?
Based on an FTC
presentation made in September 2014, they highlighted 19 Cases to Watch, which has them targeting almost every
major brand and generic pharmaceutical company. However, with the complexities
involved, this list is continuously evolving:
The
cases (by name of the brand product) Actos,
Adderall,
Aggrenox,
AndroGel,
Cipro,
Effexor,
K-Dur, Lamictal, Lidoderm,
Lipitor,
Loestrin,
Nexium,
Niaspan,
Opana,
Provigil,
Skelaxin,
Solodyn,
Wellbutrin.The
brand companies involvedAbbvie,
Abbott,
AstraZeneca,
Bayer,
Besins,
Biovail,
Boehringer,
Cephalon,
Endo,
GlaxoSmithKline,
King,
Medicis,
Pfizer,
Shire,
Schering,
Takeda,
Warner
Chilcott, Wyeth.The
generic companies Actavis
, Barr,
Duramed,
Dr. Reddy’s, HMR, Impax,
Lupin,
Mutual,
Mylan, Par, Perrigo,
Ranbaxy,
Rugby, Sandoz,
Teva,
Upsher
Smith.
Our view:
Pharmaceutical companies,
lawyers and the FTC will be busy for the coming few years, since there are a
series of suits, which will be challenging settlements reached between brand
and generic pharmaceutical companies.
While patents
provide temporary monopolies to promote innovation, brand drug manufacturers
will need to resort to more innovative ways of sustaining their profits.
Click here and learn about the different strategies adopted in the United States to block generics?
Impressions: 3400
https://www.pharmacompass.com/radio-compass-blog/haunted-teva-s-1-2-billion-pay-for-delay-penalty-which-companies-will-get-hit-next
#PharmaFlow by PHARMACOMPASS
04 Jun 2015
Over
700 commonly used generic medicines were
recommended for suspension by the European Medicines Agency (EMA) based on data
integrity concerns, over clinical studies conducted at GVK Biosciences in
Hyderabad, India.What
will be the global fallout of the European decision? The European decision has
impacted products from companies such as:Abbott Laboratories, Accord Healthcare (Intas), Actavis, Alembic, Apotex, Betapharm (Dr. Reddy’s), Brown & Burk UK, Fair Med Healthcare AG, Glenmark, Lupin, Micro Labs, Mylan, Orion Corporation, Ranbaxy, Ratiopharm, Sandoz, Sanofi-Aventis, Stada, Teva, Torrent, Wockhardt, Zydus… and many, many more.The
original recommendation of suspending
some of the medicines
made in January 2015, was an outcome of an inspection of GVK Biosciences’ site in Hyderabad (GVK BIO is a Clinical Research Organization-
CRO) by the
French medicines agency (ANSM) through the EMA. The EMA stated in their official release: “The
inspection revealed data manipulations of electrocardiograms (ECGs) during the
conduct of some studies of generic medicines, which appeared to have taken
place over a period of at least five years. Their systematic nature, the
extended period of time during which they took place and the number of members
of staff involved cast doubt on the integrity of the conduct of trials at the
site.” 1000 drugs reviewed// 700
rejectedWhile
over 1,000 pharmaceutical forms and strengths were reviewed at the GVK site,
over 300 of them had sufficient supporting data available from other sources.
As a result, these medicines were allowed to remain on the market in the EU.However, for the over 700 other medicines, the EMA after its second review, maintained its previous recommendation of January 2015, to suspend medicines, where no additional supporting data from other studies was available. Only one exception after that second review was spared from suspension, as the company was able to address the EMA’s concerns: it was Bivolet Nebivolol (5 mg tablets/ marketing authorisation holder: Neo Balkanika EOOD).While the agency noted that “there is no evidence of harm or
lack of effectiveness linked to the conduct of studies by GVK Biosciences at
Hyderabad. Some of these medicines may remain on the market” if they are of critical importance for patients. However, the recommendation
will now be sent to the European Commission for a legally binding decision,
which will apply to Member States regardless of the decision taken in the
interim period.The updated list of medicines for which, the CHMP (Committee
for Medicinal Products for Human Use) recommends suspension, is available on the EMA website. Companies
are given 12 months to submit additional data. The potential global impact of the European
suspensions?The GVK Biosciences
scandal is almost as severe in magnitude and impact, as the data falsification
concerns, which were discovered at Ranbaxy (Katherine Eban’s stunning investigation in Fortune, “Dirty Medicine” covers this extensively). One of the main promoters of GVK Biosciences is Mr. D.S. Brar who was CEO & Managing Director of Ranbaxy from 1999-2004. The impact of GVK
Biosciences’ misdeeds is already being felt on new product launches. Mylan recently withdrew its European application for generic
Abilify (aripiprazole) (2014 sales US$6.2x billion) citing “identification of major GCP issues (Good
Clinical Practices).” What about the impact on the US market?In 2010, FDA discovered data integrity
violations, which bankrupted
clinical research organization, Cetero Research/PRACS. Based on the Cetero findings
in the United States, the EMA suspended seven drugs. Now it remains to
be seen, how the FDA will handle the data integrity concerns found in Europe
since products like repaglinide & candesartan cilexitil (Mylan), levetiracetam (Dr. Reddy’s), clonazepam (Sandoz), metformin hydrochloride (Actavis), tacrolimus (Panacea Biotech) all have U.S. FDA approvals. Leading GVK Biosciences’ defense is the Indian government, who warned last month that if the European Union does not reconsider their decision, it may go to the World Trade Organization. The Indian government’s position is based on an appeal by GVK Biosciences, which made the “Indian government set up a panel of experts last year to investigate
the matter and found no manipulation”, GVK Biosciences CEO Manni Kantipudi told Reuters.However, globally reputed GMP expert, Lachman Consultants, believes that the GVK Bioscience episode “could potentially impact data integrity, similar to the Cetero/PRACS
case”.It’s clear for us that this is not the end of the story…
Impressions: 4081
https://www.pharmacompass.com/radio-compass-blog/will-data-integrity-concerns-on-clinical-trials-done-at-gvk-biosciences-go-beyond-europe
#PharmaFlow by PHARMACOMPASS
28 May 2015
