June
1. Ipca and Oncobiologics Create
Strategic Biosimilar Partnership
Ipca Laboratories
Ltd., India and Oncobiologics, Inc., USA announced today the creation of a
two-part alliance for the development, manufacture and commercialization of
biosimilar monoclonal antibody products. Under the first part of the agreement,
Ipca will in-license and commercialize biosimilar products for the India and
associated markets. These products will be developed by Oncobiologics to US FDA
and EU regulatory standards for global commercialization. Initial manufacturing
will occur in the USA by Oncobiologics and later by Ipca in India. http://www.pharmpro.com/news/2014/06/ipca-and-oncobiologics-create-strategic-biosimilars-partnership
2. Cheap Drug Greatly Boosts Prostate Cancer
Survival
A cheap, decades-old
chemotherapy drug extended life by more than a year when added to standard
hormone therapy for men whose prostate cancer has widely spread, doctors
reported Sunday. Men who received docetaxel, sold as Taxotere and in generic
form, lived nearly 58 months versus 44 months for those not given the drug, a
major study found. http://www.pharmpro.com/news/2014/06/cheap-drug-greatly-boosts-prostate-cancer-survival
3. Worldwide Pharma Industry Marketing
Investment Flat in 2013
Cegedim Strategic
Data (CSD) has released results on pharmaceutical marketing investments for
full year 2013. Worldwide, industry investment in pharmaceuticals sales force
and marketing channels remained flat in 2013, at just under [Eur] 85 billion
constant US dollars. Notably, the leading 10 multinationals, ranked by
promotional expenditure, all reduced investment during the 12 months to
December 2013.
http://www.pharmpro.com/news/2014/06/worldwide-pharma-industry-marketing-investment-flat-2013
4. Ranbaxy Decision Shows Why FDA Reluctant to
Rely on European Inspections
The
European Medicines Agency (EMA) Thursday said it was lifting a ban on a Ranbaxy
Laboratories plant in India whose products the FDA also has banned and is not
ready to accept.
http://www.fiercepharma.com/story/ranbaxy-decision-shows-why-fda-reluctant-rely-european-inspections/2014-06-06
5. FDA Panel Advises Against More Clinical
Trials for Opioid Constipation Drugs
An FDA panel advised
the agency against requiring more large clinical studies for the cardiovascular
risks of drugs that treat opioid-induced constipation, relieving drug-makers
like AstraZeneca ($AZN), Salix Pharmaceuticals ($SLX) and others from bearing
the burden of further clinical safety trials. http://www.fiercepharma.com/story/fda-panel-advises-against-more-clinical-trials-opioid-constipation-drugs/2014-06-12
6. After 4-year Benicar Review, FDA Slaps
Aside Heart-Risk Worries
The
FDA finally wrapped up its review of Benicar safety. After four years of
sifting data, the agency says it found “no clear evidence” that Daiichi
Sankyo’s blockbuster blood pressure drug increased the risk of heart attack.
But the agency will require new safety-related data on Benicar’s official
label. http://www.fiercepharma.com/story/after-4-year-benicar-review-fda-slaps-aside-heart-risk-worries/2014-06-25
7. Researchers Link Brain Gene to Kidney Cancer
A
gene known to control brain growth and development is heavily involved in
promoting clear cell renal cell carcinoma, the most common form of kidney
cancer, researchers from Mayo Clinic in Florida are reporting. http://www.dddmag.com/news/2014/06/researchers-link-brain-gene-kidney-cancer
July
1. FDA Outlines Expectations for
Drug Compounders, Including Outsourcing Facilities
The U.S. Food and
Drug Administration issued several policy documents regarding compounded drug
products for human use, as part of the agency’s continuing effort to implement
the compounding provisions of the Drug Quality and Security Act (DQSA), enacted
in November 2013. The policy documents consist of a draft interim guidance, a
proposed rule, a final guidance, and two revised requests for nominations for
the bulk drug substances lists. http://www.pharmpro.com/news/2014/07/fda-outlines-expectations-drug-compounders-including-outsourcing-facilities
2. Hospira Completes Acquisition of Orchid’s
API Manufacturing and R&D Facility
Hospira has completed
the acquisition of an active pharmaceutical ingredient (API) manufacturing
facility and an associated research and development (R&D) facility from
Orchid Chemicals & Pharmaceuticals Ltd., an Indian pharmaceuticals company,
for approximately $218 million, after settling prior advances of approximately
$30 million. http://www.pharmpro.com/news/2014/07/hospira-completes-acquisition-orchids-api-manufacturing-and-r-d-facility
3. Missouri Governor Vetoes Health Navigator
Limits
Missouri Gov. Jay Nixon vetoed
legislation Monday that would have limited who could work in the state as a
health insurance guide and blamed a national conservative group for injecting
an error into the model legislation.
http://www.pharmpro.com/news/2014/07/missouri-governor-vetoes-health-navigator-limits
4. WHO: Basic Hygiene Can Help Prevent MERS
Spread
A World Health
Organization official on Thursday urged millions of Muslims making the
pilgrimage to Mecca, Saudi Arabia, to exercise basic hygiene as mass gatherings
pose risks of spreading the Middle East respiratory syndrome. http://www.pharmpro.com/news/2014/07/who-basic-hygiene-can-help-prevent-mers-spread
5. Salix Pharmaceuticals to Combine with Cosmo
Technologies to Form Salix Pharmaceuticals, plc
Salix
Pharmaceuticals, Ltd. and Cosmo Pharmaceuticals S.p.A. today announced a
definitive merger agreement under which Salix will combine with Cosmo
Technologies Limited (“Cosmo Tech”), a subsidiary of Cosmo. Under the terms of
the agreement, Salix will become a wholly-owned subsidiary of Irish domiciled
Cosmo Tech. http://www.pharmpro.com/news/2014/07/salix-pharmaceuticals-combine-cosmo-technologies-form-salix-pharmaceuticals-plc
6. Compounding Pharmacy Oversight Changes
Signed
Gov.
Deval Patrick on Thursday signed a law he said would address a “gray area”
between state and federal oversight of the pharmacies. The measure includes new
licensing and labeling requirements and steps up fines for violations of state
rules. It also reorganizes the board that oversees pharmacies and requires the
board’s inspectors to be trained in sterile and non-sterile compounding
practices. http://www.pharmpro.com/news/2014/07/compounding-pharmacy-oversight-changes-signed
7. Galderma Finalizes Major Expansion in
Aesthetic and Corrective Dermatology in the U.S. and Canada
Galderma
S.A. announced that it has gained full rights to distribute Restylane, Perlane,
Emervel, Sculptra and Dysport from Valeant Pharmaceuticals International, Inc.
The expansion into aesthetic and corrective dermatology in the U.S. and Canada
completes Galderma’s global skin health footprint and extends its leadership in
aesthetic medicine worldwide. http://www.pharmpro.com/news/2014/07/galderma-finalizes-major-expansion-aesthetic-and-corrective-dermatology-us-and-canada
8. FDA Designates Opioid Overdose Treatment
for Fast Track Development Program
The
Fast Track program of the FDA is designed to expedite the development and
review of new drugs that are intended to treat serious or life-threatening
conditions and that demonstrate the potential to address unmet medical needs.
Fast Track-designated drugs ordinarily qualify for priority review, thereby
expediting the FDA review process. AntiOp and the FDA may also be able to
employ additional tools to expedite the FDA review process such as “rolling
submission,” whereby AntiOp may submit portions of the new drug application
(NDA) in a staged NDA submission process. http://www.pharmpro.com/news/2014/07/fda-designates-opioid-overdose-treatment-fast-track-development-program
9. Anthera Pharmaceuticals Acquires Sollpur
for Exocrine Pancreatic Insufficiency from Eli Lilly
Anthera
Pharmaceuticals today announced that it has acquired Sollpura (liprotamase), a
novel investigational Pancreatic Enzyme Replacement Therapy (“PERT”) from Eli
Lilly and Company. http://www.pharmpro.com/news/2014/07/anthera-pharmaceuticals-acquires-sollpur-exocrine-pancreatic-insufficiency-eli-lilly
10. LEO Pharma and KLOX Technologies Strike
Global Dermatology Deal
LEO
Pharma A/S and KLOX Technologies Inc. (KLOX) have entered into a worldwide
license and joint venture agreement, excluding Canada, to further develop and
commercialize KLOX’s BioPhotonic technology platform in dermatology, which
includes a CE approved treatment for moderate to severe acne. LEO Pharma will
also make an equity investment in KLOX. http://www.pharmpro.com/news/2014/07/leo-pharma-and-klox-technologies-strike-global-dermatology-deal
11. FDA Weighs Cancer Risk of Fibroid Removal
Devices
Surgeons
developed the technique as an alternative to traditional surgery, which
requires a larger incision that often results in more bleeding and longer
hospital stays. But the FDA convened a two-day meeting this week after
concluding that the risk of accidentally spreading undetected cancer to other
organs may be far more common than previously thought. http://www.pharmpro.com/news/2014/07/fda-weighs-cancer-risk-fibroid-removal-devices
12. Chiltern Acquires Ockham - Companies Merge
Operations
Chiltern
and Ockham, two full-service contract research organizations (CROs), today
announce that Chiltern has acquired 100% of Ockham and that the companies will
merge their operations. http://www.pharmpro.com/news/2014/07/chiltern-acquires-ockham-companies-merge-operations
13. CDC Director Admits Safety Problems at
Germ Labs Sourcing Facilities
The director of the
Centers for Disease Control and Prevention acknowledged Wednesday that systemic
safety problems have for years plagued federal public health laboratories that
handle dangerous germs such as anthrax and bird flu.. http://www.pharmpro.com/news/2014/07/cdc-director-admits-safety-problems-germ-labs
14. Teva Completes Acquisition of Labrys
The acquisition of
Labrys brings to Teva LBR-101, a fully humanized monoclonal antibody that binds
to calcitonin gene-related peptide (CGRP), which is currently in Phase IIb
clinical trials for prevention of chronic and episodic migraine. Teva’s
acquisition of LBR-101 complements the recent acquisition of ZECUITY ®, a novel
iontophoretic patch that delivers sumatriptan via the skin for the acute
treatment of migraine, and positions Teva to compete for leadership in the
treatment and prevention of migraine. http://www.pharmpro.com/news/2014/07/teva-completes-acquisition-labrys
15. FDA Warns of Compounded Drug Recall by
Texas Firm
The
agency says FDA inspectors recently uncovered unsanitary conditions at Unique
Pharmaceuticals’ plant in Temple, Texas. The inspections revealed production
problems in several lots of drugs that were supposed to be sterile. http://www.pharmpro.com/news/2014/07/fda-warns-compounded-drug-recall-texas-firm
16. Agents Get Subsidized ‘Obamacare’ Using
Fake IDs
Undercover
investigators using fake identities were able to secure taxpayer-subsidized
health insurance under President Barack Obama’s health care law. http://www.pharmpro.com/news/2014/07/agents-get-subsidized-obamacare-using-fake-ids
17. Study: 10M Have Gained Coverage through
Health Law
A
new study estimates that more than 10 million adults gained health insurance by
midyear as the coverage expansion under President Barack Obama’s law took hold
in much of the country. http://www.pharmpro.com/news/2014/07/study-10m-have-gained-coverage-through-health-law
18. Obama Wants Limits on US Company Mergers
Abroad
Staking
out a populist stand ahead of the midterm elections, President Barack Obama on
Thursday demanded “economic patriotism” from U.S. corporations that use legal
means to avoid U.S. taxes through overseas mergers. http://www.pharmpro.com/news/2014/07/obama-wants-limits-us-company-mergers-abroad-0
19. FDA Gives OK to Purdue Pharma’s Targiniq
ER
The
Food and Drug Administration has approved Purdue Pharma’s Targiniq ER, an
opioid painkiller with abuse-deterrent properties. The FDA said Wednesday that
Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride
extended-release tablets) is the second extended-release/long-acting opioid
analgesic with approved labeling describing its abuse-deterrent capabilities. http://www.chaindrugreview.com/suppliernews-archives/2014-07-21/fda-gives-ok-to-purdue-pharmastarginiq-er
20. Metastatic Brain Tumor Treatment Could Be
on the Horizon
A
new Cincinnati Cancer Center (CCC) study, published in the advance online
edition of the journal Oncotarget, provides hope that previously studied
SapC-DOPS could be used for treatment of brain cancer that has spread.
http://www.dddmag.com/news/2014/07/metastatic-brain-tumor-treatment-could-be-horizon
21. EU Regulator: Morning-After Pill OK for
All Women
A
commonly used morning-after pill is suitable for use by heavier women, the
European Medicines Agency said Thursday after a review of the evidence sparked
by the French manufacturer’s declaration that the drugs didn’t work in women
weighing more than 80 kilograms (176 pounds).
http://www.dddmag.com/news/2014/07/eu-regulator-morning-after-pill-ok-all-women
22. FDA Approves Malignant Hyperthermia Drug
U.S.
Food and Drug Administration (FDA) have approved Ryanodex (dantrolene sodium)
for injectable suspension indicated for the treatment of malignant hyperthermia
(MH), along with the appropriate supportive measures. MH is an inherited and
potentially fatal disorder triggered by certain anesthesia agents in
genetically susceptible individuals. http://www.dddmag.com/news/2014/07/fda-approves-malignant-hyperthermia-drug
23. Reoviruses: The Discovery of Their
Potential in Cancer Therapeutics
Reoviruses
are benign viruses with an important property: they are oncolytic, meaning they
are capable of infecting and destroying many kinds of cancer cells. The story
of how this discovery was made is an exciting one.
http://www.dddmag.com/articles/2014/07/reoviruses-discovery-their-potential-cancer-therapeutics
24. Roche Buying Seragon for Up to $1.7B
Roche
Holding AG said its U.S.-based biotech company Genentech has agreed to acquire
American biotechnology firm Seragon Pharmaceuticals Inc. for up to $1.725
billion in cash and contingency payments. http://www.dddmag.com/news/2014/07/roche-buying-seragon-17b
25. House Passes Bill to Speed FDA’s Sunscreen
Approvals
The
House passed legislation Monday to require the Food and Drug Administration to
speed approval of new types of sunscreen in the wake of a regulatory backlog
that has stalled their introduction. http://www.skinandallergynews.com/news/news/single-article/house-votes-to-speed-sunscreen-approvals/66eb81090b9f2782c98d3d99ee997307.html
August
1. Johnson & Johnson Recalls
Laparoscopic Surgery Power Morcellators
Johnson
& Johnson’s Ethicon division, the manufacturer of laparoscopic power
morcellators, announced that it is recalling all of the devices they have
manufactured. According to news reports, J&J is getting out of the power
morcellator business. Doctors and hospitals have expressed concerns about the
risk of laparoscopic power morcellators spreading cancer during laparoscopic
uterine fibroid removal. http://fortworth.legalexaminer.com/medical-devices-implants/johnson-johnson-recalls-laparoscopic-surgery-power-morcellators/
2. U.S. Ebola Virus Patient Being Treated in
Atlanta Faces Crucial Days
An
American infected with Ebola in Liberia was being treated and monitored in the
U.S. on Sunday, as doctors worked to provide care in what will be a crucial few
days in his attempt to recover from the deadly disease. http://online.wsj.com/articles/cdc-chief-seeks-to-allay-ebola-fears-1407081530
3. Low T Side Effects Androderm Patch Death
Lawsuit
The
family of Alvin Harris, from Virginia has recently filed a wrongful death
lawsuit against Androderm patch manufacturers. The plaintiffs claim that
warnings about the risk of heart attacks, strokes and blood clots side effects
with the testosterone replacement therapy were insufficient.
http://fortworth.legalexaminer.com/fda-prescription-drugs/low-t-side-effects-androderm-patch-death-lawsuit/