In 2017, deal volume in the healthcare sector overall was very active as far as mergers and acquisitions (M&A) were concerned. However, in the biotech and pharma space it was at the lowest levels in many years and a fraction of that of the boom years of 2014 and 2015.

The actual number of pharma/biotech M&A transaction announcement tracked by The Pharma Letter for full-year 2017 was just 101, compared with 130 in 2016 and 166 in 2015, which was a record year.

Moreover, in value terms, nothing has ever come close to the 1999 acquisition of Warner Lambert by Pfizer (NYSE: PFE), worth a massive $111.8 billion, but which, adjusted for inflation, would have been a staggering $160 billion.

Of the total deals tracked in 2017, just 15 had a potential value of over $1 billion to the sellers, compared with 23 in 2016 and 30 in 2015. The combined value of these 15 deals was $149.51 billion.

The $69 billion merger of CVS Health and Aetna was by far the biggest healthcare M&A deal announced in 2017, but given it is the combination of a US drugstore chain and a healthcare insurer, it was not strictly speaking a “pharmaceutical” deal as covered in The Pharma Letter’s annual review of activity in this sector.

At $30 billion, the Johnson & Johnson (NYSE: JNJ) acquisition of Swiss biotech Actelion, which was first mooted in 2016 but only formerly pursued in 2017, was by far the biggest pure biotech/pharma transaction of the year.

Besides Gilead Sciences’ (Nasdaq: GILD) $11.9 billion purchase of Kite Pharma, and Thermo Fischer’s $7.2 billion takeover of Dutch group Patheon, 2017 was a rather quiet one on the M&A front in the pharmaceutical sector.

As well at the Kite deal, which took anti-virals biotech giant Gilead into the field of cell therapy, the company made a smaller acquisition, that of USA-based Cell Design Labs for $175 million upfront plus $322 million contingent, thus gaining new technology platforms that it hopes will further enhance its research and development efforts in cellular therapy.

Read more:http://bit.ly/2CRVMDI

The US Food and Drug Administration (FDA) is set to introduce a new ‘risk-based enforcement approach’ to homeopathic drugs in America, in a bid to protect consumers who choose to use alternative treatmentsThe US Food and Drug Administration (FDA) is to introduce a new ‘risk-based enforcement approach’ to drug products that are labeled ‘homeopathic’ and available on the American market.

In a bid to protect consumers who choose to use homeopathic products, the FDA is set to update existing policy to try to better address situations where homeopathic treatments are being marketed for serious diseases or conditions, but where the products have not been shown to offer clinical benefits.

Read more: http://bit.ly/2CAPQRH

Among the list of over 300 FDA and EMA approved biopharmaceutical products, around 50% are freeze-dried – indicating that freeze-drying is the preferred way of stabilising biopharmaceutical drug products that are unstable in aqueous solution, despite the high cost and long processing time linked to this manufacturing technique.
Freeze drying is a low-temperature drying process, based on the principles of heat and mass transfer, employed to convert aqueous solutions of (heat-)labile materials into solids with sufficient stability for distribution and storage.3 Many biopharmaceuticals have limited stability in aqueous solution and are subject to a number of degradation pathways mediated by water, which might result in a lower potency or even in toxicity of the drug molecule.

Read more: http://bit.ly/2lOiGDP

A ‘triple receptor’ drug originally created to treat type 2 diabetes could be used to treat Alzheimer’s disease after researchers from China and the United Kingdom found it ‘significantly reversed memory loss’ in mice. The research appears in the journal Brain Research.

“The novel treatment holds clear promise of being developed into a new treatment for chronic neurodegenerative disorders such as Alzheimer’s disease,” said co-author Professor Christian Holscher, from Lancaster University.

This is the first time that a triple receptor drug has been used which acts in multiple ways to protect the brain from degeneration.

It combines glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), and glucagon, which are all growth factors.

Read more: http://bit.ly/2qgp1h0

Researchers in Halifax and Israel have made a promising discovery that could help doctors determine whether a person with a brain injury will develop epilepsy.

The study concluded that a type of brain activity called theta waves could be used to predict and prevent epileptic seizures, said Alon Friedman of the Brain Injury Centre at Dalhousie University.

Although promising drugs have been developed in preventing epilepsy, medical professionals need to first detect reliable “biomarkers” that predict which patients will develop the disease, he said.

“As long as you don’t know who will develop epilepsy, you cannot basically treat anyone,” Friedman said in a recent interview. “There are different treatments . . . to prevent epilepsy in patients after brain injury. The problem is that we cannot implement these treatments as long as we don’t know who should get (which treatment).”

Read more: http://bit.ly/2A8dsbm

Clinical trials of new anti-cancer therapies have often excluded patients whose disease has spread to the brain or central nervous system (CNS) or, if such patients were allowed on trial, trials have often failed to clearly capture information on the drug's effect in the brain. Today new guidelines from an international, multidisciplinary group published in the journal Lancet Oncology describe how to most appropriately address cancer patients with CNS involvement within clinical trials of anti-cancer drugs.

"Two major situations needed to be optimized. Firstly, as we've actually started to see some new anti-cancer drugs working well inside the brain, we needed to find a way to appropriately include these patients in clinical trials so that the trials could accurately capture that benefit. And secondly, for drugs that would be unlikely to work in the brain, we needed to limit risks to patients and to the drug development process," says D. Ross Camidge, MD, Ph.D., Joyce Zeff Chair in Lung Cancer Research at the University of Colorado Cancer Center, director of Thoracic Oncology at the CU School of Medicine and the lead author of the trial design guidelines.

Read more: http://bit.ly/2lDEIsS

ANI Pharmaceuticals has acquired the new drug applications (NDAs) and US marketing rights for AstraZeneca’s Atacand, Atacand HCT, Arimidex, and Casodex for $46.5m.

Atacand is an angiotensin II receptor blocker (ARB) indicated for the treatment of hypertension in adults and children 1 to <17 years of age, to lower blood pressure. The drug is also intended for the treatment of heart failure.

Atacand HCT is a combination of an angiotensin II receptor (type AT1) antagonist and a diuretic, hydrochlorothiazide. The drug has been indicated for the treatment of hypertension, to lower blood pressure.

Read more: http://bit.ly/AstraZenecaNDAs

The US Food and Drug Administration has approved a gene therapy treatment for patients with a rare inherited eye disease.

Voretigene neparvovec, which will be sold as Luxturna, is made by Philadelphia-based Spark Therapeutics Inc.

The one-time treatment is approved for children and adults with retinal dystrophy due to a mutation of the RPE65 gene, which causes severe visual impairment beginning in infancy. As it progresses, patients experience gradual loss of peripheral and central vision, which can eventually lead to blindness.

There are more than 200 genes that can cause retinal dystrophy. Patients can be tested to determine whether the cause is indeed a mutation of the RPE65 gene and they are thus a potential candidate for this new treatment.

Read more: http://bit.ly/2CSuiww

The US Food and Drug Administration (FDA) has approved ertugliflozin (Steglatro) for the treatment of glycemic control in patients with type 2 diabetes (T2D).

Ertugliflozin, an oral sodium-glucose co-transporter 2 (SGLT2) inhibitor from Merck & Co. and Pfizer, was approved as both a single therapy and fixed-dose combination therapy with dipeptidyl peptidase-4 inhibitor sitagliptin (Januvia) or common first-line therapy metformin. The combination therapies will carry the brand names Steglujan and Segluromet, respectively.

Merck and Pfizer previously announced successfully-met endpoints for the combination therapies in 2 phase 3 trials (VERTIS MET, VERTIS SITA) in June.

Read more: http://bit.ly/ErtuglifozinApproval

Kimberly-Clark has launched a campaign that aims to show contamination in labs and cleanrooms leads to low productivity, product recalls and even closures.

The “Dress for Success” campaign, which was created by Geometry Global Australia and Singapore, revolves around Kimtech Sterile Apparel, a single-use garment solution designed to the last detail to reduce human error, protecting both process and people seamlessly.

The online content features a larger-than-life product demo that gets Kimtech’s single-use apparel to face-off against reusable garments under the scrutiny of a robot arm and black light.

Read more: http://bit.ly/ContaminationControl

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BOSTON, December 18, 2017 – PAREXEL International Corporation, a leading global biopharmaceutical services provider, today introduced its enhanced Global Data Operations (GDO) solution, with augmented processes and expertise that further bolsters its world leading clinical data services, including data management, statistical programming and biostatistics.

The enhanced offering is designed to help the biopharmaceutical industry reduce time to market and R&D costs for clinical trials, including complex multi-indication trials. PAREXEL is introducing features with its GDO offering including:

Clinical Metadata Repository: A new offering which provides clients with an extensive standards library to help simplify and automate the data collection and analysis process from protocol development through final study report. The Clinical Metadata Repository provides interoperability between the clinical data collected with different data standards and supports automated mapping into CDISC’s SDTM, and ADaM, effectively reducing mapping workload in data management; and
Adaptive Trials Offering: A comprehensive set of innovative services and technologies for the design, data management, and logistics necessary for informed planning and execution of adaptive trials. Recognized as a promising approach to create upfront efficiencies and cost savings, clients can utilize adaptive trials to reduce uncertainty when planning, better inform decision making, and reduce risks for subjects and sponsors.

Read more: http://bit.ly/2yZqze2

Bigfoot Biomedical, a medical device company harnessing the power of artificial intelligence to develop systems designed to automatically and continuously optimize insulin delivery for people living with insulin-requiring diabetes, announced that the company has raised $37 million in the initial tranche of a Series B equity financing. The round is co-led by funds managed by a new investor, Janus Henderson Investors, along with Bigfoot’s largest existing investor, Quadrant Capital Advisors, Inc. Additionally, existing investors Cormorant Asset Management, Senvest Capital Inc., Senvest Management LLC, Visionnaire Ventures, JDRF T1D Fund and T1D Exchange also participated in the financing. This financing follows a previously announced $36 million Series A financing completed in 2016.

Read more: http://bit.ly/BigfootBiomedical

On 11 December 2017, Ionis Pharmaceuticals announced successful results from a Phase I/IIa trial of their drug IONIS-HTTRx, which is injected through the spinal canal and targets the underlying cause of Huntington’s disease (HD). IONIS-HTTRx, an antisense oligonucleotide (ASO), interferes with the translation of genetic information (mRNA) to the disease-causing protein: huntingtin (htt).

According to Ionis, the treatments were safe and tolerable, and caused a measurable dose-dependent reduction in the concentrations of htt within cerebrospinal fluid (CSF). The results made the headlines, and Roche has exercised an option to license the treatment for further development. This is very promising news. But I must caution that this is just one step in a chain of clinical-trial testing; the drug has not yet shown (nor has it had a fair chance to show) that it is an effective clinical treatment for HD.

Read More: http://bit.ly/HuntingtonGene

Sarasota, FL, Dec. 18, 2017 (GLOBE NEWSWIRE) -- The new report by the Zion Market Research on the “Medical Gas Market by Product (Medical Gases, Medical Pure Gases, Oxygen gases, Carbon dioxide gases, Nitrogen gases, , Helium gases, Medical Gas Mixtures, Blood gas Mixtures, Carbon dioxide-oxygen mixtures, Laser gas mixture, Aerobic mixture, Ethylene oxide, Helium oxygen mixtures), by Medical Gas Equipment (Manifolds, Outlets, Hose assemblies and valves, Alarm systems, Cylinders, Flowmeters, Regulators, Medical air compressors, Vacuum systems, Masks), By Application (Hospitals, Home Healthcare, Emergency Services), By End User (Hospitals, Home Healthcare, Emergency Services, Pharmaceutical Industry, Academic & Research Institutions), and by Region: Global Industry Perspective, Comprehensive Analysis, and Forecast, 2016- 2022” has detailed information about the market and its scope. The market is expected to reach USD 19.68 Billion by 2022.

Read more: http://bit.ly/MedicalGasMarket

Pfizer Xeljanz and Xeljanz XR have received US marketing clearance for the treatment of adults with active psoriatic arthritis (PsA) who have failed to respond or are intolerant to methotrexate or other disease-modifying antirheumatic drugs (DMARDs).

The decision means that the drug is now the first and only Janus kinase (JAK) inhibitor approved by the US Food and Drug Administration for both moderate to severe rheumatoid arthritis (RA) and active PsA, the drug giant highlighted.

Approval came after two Phase III trials assessing Xeljanz (tofacitinib) - OPAL Broaden and OPAL Beyond – hit their primary efficacy targets, showing statistically significant improvements in American College of Rheumatology 20 (ACR20) response and change from baseline in the Health Assessment Questionnaire–Disability Index (HAQ-DI) score.

Read more: http://bit.ly/PfizerXeljanz

FORT WORTH, Texas & DALLAS--(BUSINESS WIRE)--NanOlogy LLC, a clinical-stage pharmaceutical development company, today announced the first patient has been enrolled in a clinical trial of NanoPac® (nanoparticle paclitaxel) sterile suspension administered intratumorally in patients with locally advanced pancreatic adenocarcinoma. The Phase 2a dose-rising trial will evaluate the safety and preliminary efficacy of NanoPac delivered directly into the tumor by endoscopic ultrasound-guided fine needle injection in patients who have completed current standard of care treatment prior to trial entry.

Read more: http://bit.ly/NanOlogy

The US Food and Drug Administration (FDA) on Friday published two new draft guidance documents that seek to support the development of treatments that address underlying genetic mutations that often cause or contribute to diseases, and another discussing how to determine if an in vitro diagnostic (IVD) device used in a study must undergo its own FDA review, distinct from a drug study.

"New drugs are being developed based solely on their ability to target these underlying molecular subtypes," FDA Commissioner Scott Gottlieb explained in a statement. "Moreover, this same molecular change may be present as the driving factor of many different disease phenotypes. When drugs successfully target these molecular mistakes to reverse the effects of different diseases, we need a development pathway that allows the new drug to pursue approval in each of these novel settings on the basis of the molecular marker that the drug targets. In the setting of oncology, this is often referred to as tissue agnostic drug development."

Read more: http://bit.ly/FDADraftGuidances

Biom’Up (Paris:BUP), specialist in surgical hemostasis, announces today that it has received FDA marketing approval for HEMOBLAST™ Bellows, its flagship product, 7 months ahead of schedule.
This pre-marketing approval (PMA), which allows a Class III medical device to be marketed in the United States, is the most stringent pathway to approval by FDA for devices. The PMA application is based on scientific and clinical data demonstrating that the device is safe and effective for patients and users under usage prerequisites.
HEMOBLAST™ Bellows, a best in class hemostatic product that aims to control bleeding during surgical procedures (heart surgery, general surgery, orthopedic surgery, etc.) is thus now accessible to American surgeons.

Read more: http://bit.ly/BiomUpFDA

One of the world's biggest pharmaceutical firms has signed an agreement with Cambridge's Horizon Discovery Group.

Roche has sealed a deal with Horizon which will see the two companies developing immunohistochemistry (IHC) assays, which are used in the development of new drugs. Horizon will develop and provide a type of genetic biomarker, known as NTRK, to Roche. Rearranged NTRK genes have recently emerged as promising targets for cancer therapy, and a number of novel compounds have been developed against the fusion proteins that arise from these molecular alterations.

Read more: http://bit.ly/HorizonPharma

NEW YORK (GenomeWeb) – An international team led by investigators at University College London has identified a handful of genetic loci associated with a neurodegenerative condition known as dementia with Lewy bodies (DLB).

The researchers brought together data from dozens of centers around the world for a genome-wide association study involving more than 1,700 individuals with DLB and nearly 4,500 without. As they reported online today in the Lancet Neurology, their analysis led to three genome-wide significant DLB-linked loci — a set that was largely distinct from variants implicated in related neurological conditions, such as Alzheimer's disease or Parkinson's disease.
"Our findings clarify the disease's distinctive genetic signature, which should, in the future, help improve clinical trials, and lead to more targeted treatments," senior author Jose Bras, a molecular neuroscience researcher at University College London's Institute of Neurology and Alzheimer's Society, said in a statement.

Although DLB makes up a significant subset of overall dementia cases, the team explained, it can be tricky to distinguish it from Alzheimer's or Parkinson's due to overlap between some of the symptoms of these conditions.

Read more: http://bit.ly/genomewebDementia

Assembly Biosciences has never turned a profit and is still at least four years from launching its first product. But investors have become so bullish on its prospects that they’ve pushed its stock market value to nearly $1 billion.

In recent months, the 5-year-old Carmel biotech has won plenty of attention from Wall Street and has secured more than $100 million through licensing deals and a stock offering to help fund expensive clinical trials.

In January, the company raised $50 million in a licensing deal with pharmaceutical giant Allergan Plc, which bought the rights to develop Assembly Biosciences’ early-stage compounds for severe gastrointestinal disorders, such as ulcerative colitis, Crohn’s disease, irritable bowel syndrome and related conditions. The first drug could enter the clinic for testing next year, analysts said.

And in November, the company raised another $60 million in a secondary stock offering.

Read more: http://bit.ly/AssemblyBiosciences

Rise came after Chinese state agency officially recognised results of Phase 1 tests here for registration of new medications in mainland.
Hong Kong is playing an increasingly important role in speeding up the registration of new pharmaceuticals and therapies globally, with the number of clinical trials conducted in the city having surged significantly in the past year, the city’s two clinical trial centres told the Post.The centres at the University of Hong Kong and Chinese University have seen a multifold increase in the number of Phase 1 clinical trials – the first of three phases before a new medication enters the market – commissioned by overseas and Chinese pharmaceutical companies.
There have been in total 26 ongoing or completed trials at the two centres since July 2016, compared with fewer than 10 in the preceding three years. The pharmaceuticals and therapies on trial include potential treatments for cancer, hepatitis, diabetes, cardiovascular diseases and infectious diseases.

Read more: http://bit.ly/HongKongClinicalTrials

Recent research found a correlation between the upfront time to build and release a clinical database and its impact on downstream data management processes in conducting and completing trials. Richard Young reviews the study findings and offers guidance to improve the process.

Clinical trials continue to increase in complexity and scope. A typical phase 3 protocol, for example, now has many more endpoints, procedures, and data points collected compared to a decade ago.1 At the same time, data management processes have become more complicated, as contract research organisations (CROs) and sponsors manage a variety of clinical trial data. Real-world evidence, electronic clinical outcome assessments, mobile device-driven data, social media communities, and electronic health and medical records are some of the new data sources now captured during clinical trials.

The volume and diversity of data presents integration, compatibility, and interoperability challenges that the pharma industry must address in order to optimise drug development.

A new survey we conducted with the US Tufts Center for the Study of Drug Development (CSDD) examines the state of clinical data management in life sciences and its impact on drug development. One of the largest, most in-depth studies of clinical data management professionals, the 2017 eClinical Landscape Study found a correlation between the upfront time to build and release the clinical database and its impact on downstream data management processes in conducting and completing trials.

“The study results indicate that companies face a growing number of challenges in building and managing clinical study databases,” said Ken Getz, research associate professor and director at the Tufts CSDD.

Read more: http://bit.ly/DataManagementImpact

Daehwa Pharmaceuticals said that it has launched phase 2/3 clinical trials for Liporaxel, the world's first oral paclitaxel product for relapsed or metastatic breast cancer.

The announcement came after the company enrolled its first patient in the optimal study trial on Monday. The company plans to follow up the optimal study trial with 34 patients participating in phase 2 clinical trials at eight institutions in Korea, and 476 patients participating in phase 3 trials.

The clinical trials will evaluate the efficacy and safety of Liporaxel as a first-line therapy in patients with relapsed or metastatic breast cancer.

Paclitaxel, which is the main ingredient of the drug, is a common cytotoxic anticancer drug. It has been difficult to develop oral formulations due to problems such as absorption inhibition. However, the company successfully developed the oral formulation through its patented “DH-LASED platform” technology and obtained sales rights for stomach cancer last year.

Read more: http://bit.ly/DaehwaPharma